Cohort profile: the Netherlands Cohort Study on Acute HIV infection (NOVA), a prospective cohort study of people with acute or early HIV infection who immediately initiate HIV treatment

PurposeInitiation of combination antiretroviral therapy (cART) during acute or early HIV-infection (AEHI) limits the size of the viral reservoir and preserves immune function. This renders individuals who started cART during AEHI promising participants in HIV-cure trials. Therefore, we established a...

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Published in:BMJ open Vol. 11; no. 11; p. e048582
Main Authors: Dijkstra, Maartje, Prins, Henrieke, Prins, Jan M, Reiss, Peter, Boucher, Charles, Verbon, Annelies, Rokx, Casper, de Bree, Godelieve
Format: Journal Article
Language:English
Published: England British Medical Journal Publishing Group 29.11.2021
BMJ Publishing Group LTD
BMJ Publishing Group
Series:Cohort profile
Subjects:
Adult
Anti-HIV Agents - therapeutic use
Antigens
Antiretroviral drugs
Antiviral drugs
Cohort analysis
Cohort Studies
Drug therapy
Emtricitabine - therapeutic use
Epidemiology
HIV
HIV & AIDS
HIV Infections - drug therapy
Human immunodeficiency virus
Humans
Immunology
Infections
Infectious Diseases
Lymphocytes
Male
Netherlands - epidemiology
Prospective Studies
Treatment Outcome
Viral Load
Netherlands
epidemiology
HIV & AIDS
immunology
ISSN:2044-6055, 2044-6055
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Summary:PurposeInitiation of combination antiretroviral therapy (cART) during acute or early HIV-infection (AEHI) limits the size of the viral reservoir and preserves immune function. This renders individuals who started cART during AEHI promising participants in HIV-cure trials. Therefore, we established a multicentre prospective cohort study in the Netherlands that enrols people with AEHI. In anticipation of future cure trials, we will longitudinally investigate the properties of the viral reservoir size and HIV-specific immune responses among cohort participants.ParticipantsParticipants immediately initiate intensified cART: dolutegravir, emtricitabine/tenofovir and darunavir/ritonavir (DRV/r). After 4 weeks, once baseline resistance data are available, DRV/r is discontinued. Three study groups are assembled based on the preparedness of individuals to participate in the extensiveness of sampling. Participants accepting immediate treatment and follow-up but declining additional sampling are included in study group 1 (‘standard’) and routine diagnostic procedures are performed. Participants willing to undergo blood, leukapheresis and semen sampling are included in study group 2 (‘less invasive’). In study group 3 (‘extended’), additional tissue (gut-associated lymphoid tissue, peripheral lymph node) and cerebrospinal fluid sampling are performed.Findings to dateBetween 2015 and 2020, 140 individuals with AEHI have been enrolled at nine study sites. At enrolment, median age was 36 (IQR 28–47) years, and 134 (95.7%) participants were men. Distribution of Fiebig stages was as follows: Fiebig I, 3 (2.1%); II, 20 (14.3%); III, 7 (5.0%); IV, 49 (35.0%); V, 39 (27.9%); VI, 22 (15.7%). Median plasma HIV RNA was 5.9 (IQR 4.7–6.7) log10 copies/mL and CD4 count 510 (IQR 370–700) cells/mm3. Median time from cART initiation to viral suppression was 8.0 (IQR 4.0–16.0) weeks.Future plansThe Netherlands Cohort Study on Acute HIV infection remains open for participant enrolment and for additional sites to join the network. This cohort provides a unique nationwide platform for conducting future in-depth virological, immunological, host genetic and interventional studies investigating HIV-cure strategies.
Bibliography:Cohort profile
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MD and HP are joint first authors.
CR and GdB are joint senior authors.
ISSN:2044-6055
2044-6055
DOI:10.1136/bmjopen-2020-048582