Dolutegravir as First- or Second-Line Treatment for HIV-1 Infection in Children

In an open-label, randomized, noninferiority trial, dolutegravir-based antiretroviral therapy was compared with standard care in children and adolescents starting first- or second-line therapy for HIV type 1 infection. Dolutegravir-based ART was superior to standard-care ART.

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Bibliographic Details
Published in:	The New England journal of medicine Vol. 385; no. 27; pp. 2531 - 2543
Main Authors:	Turkova, Anna, White, Ellen, Mujuru, Hilda A, Kekitiinwa, Adeodata R, Kityo, Cissy M, Violari, Avy, Lugemwa, Abbas, Cressey, Tim R, Musoke, Philippa, Variava, Ebrahim, Cotton, Mark F, Archary, Moherndran, Puthanakit, Thanyawee, Behuhuma, Osee, Kobbe, Robin, Welch, Steven B, Bwakura-Dangarembizi, Mutsa, Amuge, Pauline, Kaudha, Elizabeth, Barlow-Mosha, Linda, Makumbi, Shafic, Ramsagar, Nastassja, Ngampiyaskul, Chaiwat, Musoro, Godfrey, Atwine, Lorna, Liberty, Afaaf, Musiime, Victor, Bbuye, Dickson, Ahimbisibwe, Grace M, Chalermpantmetagul, Suwalai, Ali, Shabinah, Sarfati, Tatiana, Wynne, Ben, Shakeshaft, Clare, Colbers, Angela, Klein, Nigel, Bernays, Sarah, Saïdi, Yacine, Coelho, Alexandra, Grossele, Tiziana, Compagnucci, Alexandra, Giaquinto, Carlo, Rojo, Pablo, Ford, Deborah, Gibb, Diana M
Format:	Journal Article
Language:	English
Published:	United States Massachusetts Medical Society 30.12.2021
Subjects:	Acquired immune deficiency syndrome Administration, Oral Adolescence Adolescent Adolescents Adverse events AIDS Alkynes - therapeutic use Anti-Retroviral Agents - adverse effects Anti-Retroviral Agents - therapeutic use Antiretroviral drugs Antiretroviral therapy Benzoxazines - therapeutic use Caregivers Child Child, Preschool Children Cholesterol - blood Cyclopropanes - therapeutic use Drug Therapy, Combination Efavirenz FDA approval Female Global Health Heterocyclic Compounds, 3-Ring - administration & dosage Heterocyclic Compounds, 3-Ring - adverse effects Heterocyclic Compounds, 3-Ring - therapeutic use HIV HIV Infections - drug therapy HIV Infections - virology HIV Integrase Inhibitors - administration & dosage HIV Integrase Inhibitors - adverse effects HIV Integrase Inhibitors - therapeutic use HIV Protease Inhibitors - therapeutic use HIV-1 - isolation & purification Human immunodeficiency virus Humans Immune system Infections Infectious Disease Integrase Life Sciences Male Mutation Oxazines - administration & dosage Oxazines - adverse effects Oxazines - therapeutic use Pediatrics Pediatrics General Piperazines - administration & dosage Piperazines - adverse effects Piperazines - therapeutic use Proteinase inhibitors Pyridones - administration & dosage Pyridones - adverse effects Pyridones - therapeutic use Santé publique et épidémiologie Teenagers Viral Load - drug effects
ISSN:	0028-4793, 1533-4406, 1533-4406
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Abstract	In an open-label, randomized, noninferiority trial, dolutegravir-based antiretroviral therapy was compared with standard care in children and adolescents starting first- or second-line therapy for HIV type 1 infection. Dolutegravir-based ART was superior to standard-care ART.
AbstractList	Background: Children with human immunodeficiency virus type 1 (HIV-1) infection have limited options for effective antiretroviral treatment (ART).Methods: We conducted an open-label, randomized, noninferiority trial comparing three-drug ART based on the HIV integrase inhibitor dolutegravir with standard care (non-dolutegravir-based ART) in children and adolescents starting first- or second-line ART. The primary end point was the proportion of participants with virologic or clinical treatment failure by 96 weeks, as estimated by the Kaplan-Meier method. Safety was assessed.Results: From September 2016 through June 2018, a total of 707 children and adolescents who weighed at least 14 kg were randomly assigned to receive dolutegravir-based ART (350 participants) or standard care (357). The median age was 12.2 years (range, 2.9 to 18.0), the median weight was 30.7 kg (range, 14.0 to 85.0), and 49% of the participants were girls. By design, 311 participants (44%) started first-line ART (with 92% of those in the standard-care group receiving efavirenz-based ART), and 396 (56%) started second-line ART (with 98% of those in the standard-care group receiving boosted protease inhibitor-based ART). The median follow-up was 142 weeks. By 96 weeks, 47 participants in the dolutegravir group and 75 in the standard-care group had treatment failure (estimated probability, 0.14 vs. 0.22; difference, -0.08; 95% confidence interval, -0.14 to -0.03; P = 0.004). Treatment effects were similar with first- and second-line therapies (P = 0.16 for heterogeneity). A total of 35 participants in the dolutegravir group and 40 in the standard-care group had at least one serious adverse event (P = 0.53), and 73 and 86, respectively, had at least one adverse event of grade 3 or higher (P = 0.24). At least one ART-modifying adverse event occurred in 5 participants in the dolutegravir group and in 17 in the standard-care group (P = 0.01).Conclusions: In this trial involving children and adolescents with HIV-1 infection who were starting first- or second-line treatment, dolutegravir-based ART was superior to standard care. (Funded by ViiV Healthcare; ODYSSEY ClinicalTrials.gov number, NCT02259127; EUDRACT number, 2014-002632-14; and ISRCTN number, ISRCTN91737921.). In an open-label, randomized, noninferiority trial, dolutegravir-based antiretroviral therapy was compared with standard care in children and adolescents starting first- or second-line therapy for HIV type 1 infection. Dolutegravir-based ART was superior to standard-care ART. Children with human immunodeficiency virus type 1 (HIV-1) infection have limited options for effective antiretroviral treatment (ART).BACKGROUNDChildren with human immunodeficiency virus type 1 (HIV-1) infection have limited options for effective antiretroviral treatment (ART).We conducted an open-label, randomized, noninferiority trial comparing three-drug ART based on the HIV integrase inhibitor dolutegravir with standard care (non-dolutegravir-based ART) in children and adolescents starting first- or second-line ART. The primary end point was the proportion of participants with virologic or clinical treatment failure by 96 weeks, as estimated by the Kaplan-Meier method. Safety was assessed.METHODSWe conducted an open-label, randomized, noninferiority trial comparing three-drug ART based on the HIV integrase inhibitor dolutegravir with standard care (non-dolutegravir-based ART) in children and adolescents starting first- or second-line ART. The primary end point was the proportion of participants with virologic or clinical treatment failure by 96 weeks, as estimated by the Kaplan-Meier method. Safety was assessed.From September 2016 through June 2018, a total of 707 children and adolescents who weighed at least 14 kg were randomly assigned to receive dolutegravir-based ART (350 participants) or standard care (357). The median age was 12.2 years (range, 2.9 to 18.0), the median weight was 30.7 kg (range, 14.0 to 85.0), and 49% of the participants were girls. By design, 311 participants (44%) started first-line ART (with 92% of those in the standard-care group receiving efavirenz-based ART), and 396 (56%) started second-line ART (with 98% of those in the standard-care group receiving boosted protease inhibitor-based ART). The median follow-up was 142 weeks. By 96 weeks, 47 participants in the dolutegravir group and 75 in the standard-care group had treatment failure (estimated probability, 0.14 vs. 0.22; difference, -0.08; 95% confidence interval, -0.14 to -0.03; P = 0.004). Treatment effects were similar with first- and second-line therapies (P = 0.16 for heterogeneity). A total of 35 participants in the dolutegravir group and 40 in the standard-care group had at least one serious adverse event (P = 0.53), and 73 and 86, respectively, had at least one adverse event of grade 3 or higher (P = 0.24). At least one ART-modifying adverse event occurred in 5 participants in the dolutegravir group and in 17 in the standard-care group (P = 0.01).RESULTSFrom September 2016 through June 2018, a total of 707 children and adolescents who weighed at least 14 kg were randomly assigned to receive dolutegravir-based ART (350 participants) or standard care (357). The median age was 12.2 years (range, 2.9 to 18.0), the median weight was 30.7 kg (range, 14.0 to 85.0), and 49% of the participants were girls. By design, 311 participants (44%) started first-line ART (with 92% of those in the standard-care group receiving efavirenz-based ART), and 396 (56%) started second-line ART (with 98% of those in the standard-care group receiving boosted protease inhibitor-based ART). The median follow-up was 142 weeks. By 96 weeks, 47 participants in the dolutegravir group and 75 in the standard-care group had treatment failure (estimated probability, 0.14 vs. 0.22; difference, -0.08; 95% confidence interval, -0.14 to -0.03; P = 0.004). Treatment effects were similar with first- and second-line therapies (P = 0.16 for heterogeneity). A total of 35 participants in the dolutegravir group and 40 in the standard-care group had at least one serious adverse event (P = 0.53), and 73 and 86, respectively, had at least one adverse event of grade 3 or higher (P = 0.24). At least one ART-modifying adverse event occurred in 5 participants in the dolutegravir group and in 17 in the standard-care group (P = 0.01).In this trial involving children and adolescents with HIV-1 infection who were starting first- or second-line treatment, dolutegravir-based ART was superior to standard care. (Funded by ViiV Healthcare; ODYSSEY ClinicalTrials.gov number, NCT02259127; EUDRACT number, 2014-002632-14; and ISRCTN number, ISRCTN91737921.).CONCLUSIONSIn this trial involving children and adolescents with HIV-1 infection who were starting first- or second-line treatment, dolutegravir-based ART was superior to standard care. (Funded by ViiV Healthcare; ODYSSEY ClinicalTrials.gov number, NCT02259127; EUDRACT number, 2014-002632-14; and ISRCTN number, ISRCTN91737921.). AbstractBackgroundChildren with human immunodeficiency virus type 1 (HIV-1) infection have limited options for effective antiretroviral treatment (ART).MethodsWe conducted an open-label, randomized, noninferiority trial comparing three-drug ART based on the HIV integrase inhibitor dolutegravir with standard care (non–dolutegravir-based ART) in children and adolescents starting first- or second-line ART. The primary end point was the proportion of participants with virologic or clinical treatment failure by 96 weeks, as estimated by the Kaplan–Meier method. Safety was assessed.ResultsFrom September 2016 through June 2018, a total of 707 children and adolescents who weighed at least 14 kg were randomly assigned to receive dolutegravir-based ART (350 participants) or standard care (357). The median age was 12.2 years (range, 2.9 to 18.0), the median weight was 30.7 kg (range, 14.0 to 85.0), and 49% of the participants were girls. By design, 311 participants (44%) started first-line ART (with 92% of those in the standard-care group receiving efavirenz-based ART), and 396 (56%) started second-line ART (with 98% of those in the standard-care group receiving boosted protease inhibitor–based ART). The median follow-up was 142 weeks. By 96 weeks, 47 participants in the dolutegravir group and 75 in the standard-care group had treatment failure (estimated probability, 0.14 vs. 0.22; difference, –0.08; 95% confidence interval, −0.14 to −0.03; P=0.004). Treatment effects were similar with first- and second-line therapies (P=0.16 for heterogeneity). A total of 35 participants in the dolutegravir group and 40 in the standard-care group had at least one serious adverse event (P=0.53), and 73 and 86, respectively, had at least one adverse event of grade 3 or higher (P=0.24). At least one ART-modifying adverse event occurred in 5 participants in the dolutegravir group and in 17 in the standard-care group (P=0.01).ConclusionsIn this trial involving children and adolescents with HIV-1 infection who were starting first- or second-line treatment, dolutegravir-based ART was superior to standard care. (Funded by ViiV Healthcare; ODYSSEY ClinicalTrials.gov number, NCT02259127; EUDRACT number, 2014-002632-14; and ISRCTN number, ISRCTN91737921.) Children with human immunodeficiency virus type 1 (HIV-1) infection have limited options for effective antiretroviral treatment (ART). We conducted an open-label, randomized, noninferiority trial comparing three-drug ART based on the HIV integrase inhibitor dolutegravir with standard care (non-dolutegravir-based ART) in children and adolescents starting first- or second-line ART. The primary end point was the proportion of participants with virologic or clinical treatment failure by 96 weeks, as estimated by the Kaplan-Meier method. Safety was assessed. From September 2016 through June 2018, a total of 707 children and adolescents who weighed at least 14 kg were randomly assigned to receive dolutegravir-based ART (350 participants) or standard care (357). The median age was 12.2 years (range, 2.9 to 18.0), the median weight was 30.7 kg (range, 14.0 to 85.0), and 49% of the participants were girls. By design, 311 participants (44%) started first-line ART (with 92% of those in the standard-care group receiving efavirenz-based ART), and 396 (56%) started second-line ART (with 98% of those in the standard-care group receiving boosted protease inhibitor-based ART). The median follow-up was 142 weeks. By 96 weeks, 47 participants in the dolutegravir group and 75 in the standard-care group had treatment failure (estimated probability, 0.14 vs. 0.22; difference, -0.08; 95% confidence interval, -0.14 to -0.03; P = 0.004). Treatment effects were similar with first- and second-line therapies (P = 0.16 for heterogeneity). A total of 35 participants in the dolutegravir group and 40 in the standard-care group had at least one serious adverse event (P = 0.53), and 73 and 86, respectively, had at least one adverse event of grade 3 or higher (P = 0.24). At least one ART-modifying adverse event occurred in 5 participants in the dolutegravir group and in 17 in the standard-care group (P = 0.01). In this trial involving children and adolescents with HIV-1 infection who were starting first- or second-line treatment, dolutegravir-based ART was superior to standard care. (Funded by ViiV Healthcare; ODYSSEY ClinicalTrials.gov number, NCT02259127; EUDRACT number, 2014-002632-14; and ISRCTN number, ISRCTN91737921.).
Author	Coelho, Alexandra Ali, Shabinah Ngampiyaskul, Chaiwat Kityo, Cissy M Colbers, Angela Bbuye, Dickson Cressey, Tim R Rojo, Pablo Giaquinto, Carlo Saïdi, Yacine Amuge, Pauline Liberty, Afaaf Atwine, Lorna Mujuru, Hilda A Cotton, Mark F Kobbe, Robin Turkova, Anna Ford, Deborah Violari, Avy Shakeshaft, Clare Compagnucci, Alexandra Ahimbisibwe, Grace M Gibb, Diana M Kaudha, Elizabeth Archary, Moherndran Grossele, Tiziana Wynne, Ben Musiime, Victor Welch, Steven B Musoro, Godfrey Klein, Nigel Lugemwa, Abbas Ramsagar, Nastassja Behuhuma, Osee Bwakura-Dangarembizi, Mutsa Makumbi, Shafic Sarfati, Tatiana Kekitiinwa, Adeodata R Puthanakit, Thanyawee Musoke, Philippa Chalermpantmetagul, Suwalai Barlow-Mosha, Linda Variava, Ebrahim Bernays, Sarah White, Ellen
Author_xml	– sequence: 1 givenname: Anna surname: Turkova fullname: Turkova, Anna organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 2 givenname: Ellen surname: White fullname: White, Ellen organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 3 givenname: Hilda A surname: Mujuru fullname: Mujuru, Hilda A organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 4 givenname: Adeodata R surname: Kekitiinwa fullname: Kekitiinwa, Adeodata R organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 5 givenname: Cissy M surname: Kityo fullname: Kityo, Cissy M organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 6 givenname: Avy surname: Violari fullname: Violari, Avy organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 7 givenname: Abbas surname: Lugemwa fullname: Lugemwa, Abbas organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 8 givenname: Tim R surname: Cressey fullname: Cressey, Tim R organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 9 givenname: Philippa surname: Musoke fullname: Musoke, Philippa organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 10 givenname: Ebrahim surname: Variava fullname: Variava, Ebrahim organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 11 givenname: Mark F surname: Cotton fullname: Cotton, Mark F organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 12 givenname: Moherndran surname: Archary fullname: Archary, Moherndran organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 13 givenname: Thanyawee surname: Puthanakit fullname: Puthanakit, Thanyawee organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 14 givenname: Osee surname: Behuhuma fullname: Behuhuma, Osee organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 15 givenname: Robin surname: Kobbe fullname: Kobbe, Robin organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 16 givenname: Steven B surname: Welch fullname: Welch, Steven B organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 17 givenname: Mutsa surname: Bwakura-Dangarembizi fullname: Bwakura-Dangarembizi, Mutsa organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 18 givenname: Pauline surname: Amuge fullname: Amuge, Pauline organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 19 givenname: Elizabeth surname: Kaudha fullname: Kaudha, Elizabeth organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 20 givenname: Linda surname: Barlow-Mosha fullname: Barlow-Mosha, Linda organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 21 givenname: Shafic surname: Makumbi fullname: Makumbi, Shafic organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 22 givenname: Nastassja surname: Ramsagar fullname: Ramsagar, Nastassja organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 23 givenname: Chaiwat surname: Ngampiyaskul fullname: Ngampiyaskul, Chaiwat organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 24 givenname: Godfrey surname: Musoro fullname: Musoro, Godfrey organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 25 givenname: Lorna surname: Atwine fullname: Atwine, Lorna organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 26 givenname: Afaaf surname: Liberty fullname: Liberty, Afaaf organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 27 givenname: Victor surname: Musiime fullname: Musiime, Victor organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 28 givenname: Dickson surname: Bbuye fullname: Bbuye, Dickson organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 29 givenname: Grace M surname: Ahimbisibwe fullname: Ahimbisibwe, Grace M organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 30 givenname: Suwalai surname: Chalermpantmetagul fullname: Chalermpantmetagul, Suwalai organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 31 givenname: Shabinah surname: Ali fullname: Ali, Shabinah organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 32 givenname: Tatiana surname: Sarfati fullname: Sarfati, Tatiana organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 33 givenname: Ben surname: Wynne fullname: Wynne, Ben organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 34 givenname: Clare surname: Shakeshaft fullname: Shakeshaft, Clare organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 35 givenname: Angela surname: Colbers fullname: Colbers, Angela organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 36 givenname: Nigel surname: Klein fullname: Klein, Nigel organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 37 givenname: Sarah surname: Bernays fullname: Bernays, Sarah organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 38 givenname: Yacine surname: Saïdi fullname: Saïdi, Yacine organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 39 givenname: Alexandra surname: Coelho fullname: Coelho, Alexandra organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 40 givenname: Tiziana surname: Grossele fullname: Grossele, Tiziana organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 41 givenname: Alexandra surname: Compagnucci fullname: Compagnucci, Alexandra organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 42 givenname: Carlo surname: Giaquinto fullname: Giaquinto, Carlo organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 43 givenname: Pablo surname: Rojo fullname: Rojo, Pablo organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 44 givenname: Deborah surname: Ford fullname: Ford, Deborah organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.) – sequence: 45 givenname: Diana M surname: Gibb fullname: Gibb, Diana M organization: From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Health and Development, London School of Hygiene and Tropical Medicine (S.B.), London, and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham (S.B.W.) — all in the United Kingdom; the University of Zimbabwe, Harare (H.A.M., M.B.-D., G.M.); Baylor College of Medicine, Fort Portal (A.R.K., P.A., D.B.), the Joint Clinical Research Center, Mbarara (A. Lugemwa, S.M., L.A.), and the Joint Clinical Research Center (C.M.K., E.K., V.M.), Makerere University–Johns Hopkins University Research Collaboration (P.M., L.B.-M., G.M.A.), and Makerere University (V.M.), Kampala — all in Uganda; the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg (A.V., N.R., E.V., A. Liberty), the Family Centre for Research with Ubuntu, the Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg (M.F.C.), the Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu–Natal (M.A.), and the Africa Health Research Institute (O.B., N.K.), Durban — all in South Africa; the Program for HIV Prevention and Treatment–Institut de Recherche pour le Développement Research Unit, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai (T.R.C., S.C.), the Faculty of Medicine, Chulalongkorn University (T.P.), and HIV-NAT (HIV Netherlands Australia Thailand Research Collaboration), Thai Red Cross AIDS Research Center, Bangkok (T.P.), and Prapokklao Hospital, Chanthaburi (C.N.) — all in Thailand; the First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg–Eppendorf, Hamburg, Germany (R.K.); the Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands (A. Colbers); the School of Public Health, University of Sydney, Sydney (S.B.); INSERM-ANRS SC10-US019, Essais Thérapeutiques et Maladies Infectieuses, Villejuif, France (Y.S., A. Coelho, A. Compagnucci); the Penta Foundation (T.G., C.G.), and the Department of Women and Child Health, University of Padua (C.G.) — both in Padua, Italy; and the Pediatric Infectious Diseases Unit, Hospital Universitario 12 de Octubre, Madrid (P.R.)
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/34965338$$D View this record in MEDLINE/PubMed https://hal.science/hal-04682062$$DView record in HAL
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Snippet	In an open-label, randomized, noninferiority trial, dolutegravir-based antiretroviral therapy was compared with standard care in children and adolescents... Children with human immunodeficiency virus type 1 (HIV-1) infection have limited options for effective antiretroviral treatment (ART). We conducted an... AbstractBackgroundChildren with human immunodeficiency virus type 1 (HIV-1) infection have limited options for effective antiretroviral treatment... Children with human immunodeficiency virus type 1 (HIV-1) infection have limited options for effective antiretroviral treatment (ART).BACKGROUNDChildren with... Background: Children with human immunodeficiency virus type 1 (HIV-1) infection have limited options for effective antiretroviral treatment (ART).Methods: We...
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SubjectTerms	Acquired immune deficiency syndrome Administration, Oral Adolescence Adolescent Adolescents Adverse events AIDS Alkynes - therapeutic use Anti-Retroviral Agents - adverse effects Anti-Retroviral Agents - therapeutic use Antiretroviral drugs Antiretroviral therapy Benzoxazines - therapeutic use Caregivers Child Child, Preschool Children Cholesterol - blood Cyclopropanes - therapeutic use Drug Therapy, Combination Efavirenz FDA approval Female Global Health Heterocyclic Compounds, 3-Ring - administration & dosage Heterocyclic Compounds, 3-Ring - adverse effects Heterocyclic Compounds, 3-Ring - therapeutic use HIV HIV Infections - drug therapy HIV Infections - virology HIV Integrase Inhibitors - administration & dosage HIV Integrase Inhibitors - adverse effects HIV Integrase Inhibitors - therapeutic use HIV Protease Inhibitors - therapeutic use HIV-1 - isolation & purification Human immunodeficiency virus Humans Immune system Infections Infectious Disease Integrase Life Sciences Male Mutation Oxazines - administration & dosage Oxazines - adverse effects Oxazines - therapeutic use Pediatrics Pediatrics General Piperazines - administration & dosage Piperazines - adverse effects Piperazines - therapeutic use Proteinase inhibitors Pyridones - administration & dosage Pyridones - adverse effects Pyridones - therapeutic use Santé publique et épidémiologie Teenagers Viral Load - drug effects
SubjectTermsDisplay	Global Health HIV/AIDS Infectious Disease Pediatrics Pediatrics General
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Title	Dolutegravir as First- or Second-Line Treatment for HIV-1 Infection in Children
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