ClinicalTrials.gg
Active, not recruitingNCT03296202AquiVIH-NAUpdated Jul 7, 2026

Risk of Morbidity, Mortality and Long-term Monitoring of Antiretroviral Treatment in People Living With HIV

An observational study in HIV Infections and Antiretroviral Agents, sponsored by University Hospital, Bordeaux. Active, not recruiting at 19 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.

Sponsored by University Hospital, Bordeaux · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
7,500
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 278 studies in HIV Infections with a site in France — 19 open to participants now, 27 under way, 5 of them phase 3. HIV Infections · France.

Planned enrollment
Largest of 59
7,500 · median 200
Started
2017
with 7 others
Observational
59 of 278
13 open now
Primary completion
2026-12
later than 16 of 26 live
Registered
208th of 278
by date

Among the 278 studies in HIV Infections with a site in France, this one has the largest planned enrollment of the 59 observational ones that give a count, is one of 8 that started in 2017, is one of 59 observational ones, reaches primary completion later than 16 of the 26 other live ones, and was the 208th registered.

HIV Infections

4,735 studies on the registry are indexed under HIV Infections; 245 are open to participants now.

Browse HIV Infections studies →

Open to participants now

19 of the 278 studies in HIV Infections with a site in France are open now. Recruiting first, the newest first:

14 more — sign in →

All 19 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 159 HIV Infections studies recruiting now, 104 (65%) set no upper age limit and 42 (26%) stop at 75 or younger; 31 take children under 18; 60 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

HIV infection is now a chronic disease in countries where antiretroviral treatments (ART) are largely available. Long-term follow-up is required to describe and understand the evolution of morbidities and complications as well as new treatments side effects.

The main objective of the cohort is to describe and study the evolution of HIV infection in ART-treated individuals.

Read the detailed description

The survival of people living with HIV (PLHIV) taking antiretroviral therapy (ART) is now close to what is reported in the general population in northern countries. However, PLHIV experience an increased risk of morbidities that the ANRS CO3 Aquitaine Cohort has largely contributed to describe in the last years. Among contributing factors to this excess of morbidity, immune suppression, immune activation, and exposition to cardiovascular and cancer risk factors as well as ageing represent possible intervention targets. Long-term follow-up is required to describe and understand the evolution of morbidities and complications as well as ART side effects.

Moreover, the global evaluation of health in PLHIV, including psychiatric, neurologic and social determinants and not only biomedical determinants represents one of the public health challenges of the next decade in the field of HIV infection.

The aim of the present study is to study the emerging morbidity occurring during the course of HIV infection in people treated with ART as well as to describe the tolerance and efficacy of new available ART regimens.

The follow-up of patients will be performed according to national guidelines. Demographic, clinical, biological and therapeutic data will be captured at each patient's hospital contact according to a standardized questionnaire.

All events occurring during the course of clinical management will be prospectively registered in the database according to the ICD 10th revision. A biobank will be collected from every consenting PLHIV at inclusion in the cohort and then every two years.

03

Conditions studied

  • HIV Infections
  • Antiretroviral Agents

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Keywords

  • HIV
  • cohort studies
  • antiretroviral treatment
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients infected with HIV-1 (PLHIV)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients aged over 18 years old.
  • Confirmed infection
  • Signed

Exclusion criteria

Exclusion Criteria:

  • -2 infection
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
7,500 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • HIV patients

    7500 patients infected with HIV-1

06

What researchers measure

Primary outcomes

  1. Socio-demographic characteristics of people living with the HIV

    Time frame: Each 12 months from baseline for 4 years (M48)

Secondary outcomes

  1. HIV infection characteristics of people living with the HIV

    group of infection, stage of infection, duration since first serology positive, CD4 nadir, last CD4 measurement, CD4 / CD8 ratio

    Time frame: Each 12 months from baseline for 4 years (M48)

  2. comorbidities of people living with the HIV

    Time frame: Each 12 months from baseline for 4 years (M48)

  3. co-infections of people living with the HIV

    Hepatitis B, Hepatitis C, cytomegalovirus infection...

    Time frame: Each 12 months from baseline for 4 years (M48)

  4. Therapeutics description

    naïve / treated status, dosage

    Time frame: Each 12 months from baseline for 4 years (M48)

  5. virological responses

    Time frame: Each 12 months from baseline for 4 years (M48)

07

Study locations

19 sites
  • service de médecine interne - CH d'Agen
    Agen, 47923, France
  • Médecine interne - CH d'Angoulême
    Angoulême, France
  • service de maladies infectieuses - CH de la Côte Basque
    Bayonne, 64109, France
  • service de médecine inter et maladies infectieuses - Hopital Saint André
    Bordeaux, 33075, France
  • service de médecine interne et maladies infectieuses - Hôpital Saint-André
    Bordeaux, 33075, France
  • service de maladies infectieuses et médecine tropicale - Hôpital Pellegrin
    Bordeaux, 33076, France
  • Service D'Urgences Pédiatriques
    Bordeaux, France
  • service de médecine interne et maladies infectieuses - CH de Dax
    Dax, 40107, France
  • Médecine Interne - CH de Jonzac
    Jonzac, France
  • service de médecine interne - CH d'Arcachon
    La Teste-de-Buch, 33260, France
  • service de médecine interne - CH de Libourne
    Libourne, 33505, France
  • service de médecine interne - CH d'Orthez
    Orthez, France
  • service de médecine interne et maladies infectieuses - CH de Pau
    Pau, 64000, France
  • service de médecine interne et maladies infectieuses - Groupe hospitalier Sud
    Pessac, France
  • service de médecine interne et maladies infectieuses - CH de Périgueux
    Périgueux, 24019, France
  • Médecine interne et Maladies Infectieuses - CHU de Poitiers
    Poitiers, France
  • Médecine interne - CH de Royan
    Royan, France
  • Médecine Interne - CH de Saint-Jean-D'Angely
    Saint-Jean-d'Angély, France
  • Médecine Interne - CH de Saintonge
    Saintes, France
08

References and documents

Publications

  • Devos S, Bonnet F, Hessamfar M, Neau D, Vareil MO, Leleux O, Cazanave C, Rouanes N, Duffau P, Lazaro E, Dabis F, Wittkop L, Barger D; ANRS CO3-AQUIVIH-NA-QuAliV. Tobacco, alcohol, cannabis, and illicit drug use and their association with CD4/CD8 cell count ratio in people with controlled HIV: a cross-sectional study (ANRS CO3 AQUIVIH-NA-QuAliV). BMC Infect Dis. 2023 Jan 9;23(1):16. doi: 10.1186/s12879-022-07963-6. PubMed 36624391 ↗
  • Barger D, Hessamfar M, Neau D, Vareil MO, Lazaro E, Duffau P, Rouanes N, Leleux O, Le Marec F, Erramouspe M, Wittkop L, Dabis F, Bonnet F. Assessing the psychometric properties of the French WHOQOL-HIV BREF within the ANRS CO3 Aquitaine Cohort's QuAliV ancillary study. Health Qual Life Outcomes. 2020 Jul 10;18(1):220. doi: 10.1186/s12955-020-01451-8. PubMed 32650781 ↗
  • Barger D, Leleux O, Conte V, Sapparrart V, Gapillout M, Crespel I, Erramouspe M, Delveaux S, Wittkop L, Dabis F, Bonnet F. Web-Based Module for the Collection of Electronic Patient-Reported Outcomes in People Living With HIV in Nouvelle Aquitaine, France: Usability Evaluation. JMIR Form Res. 2019 Dec 18;3(4):e15013. doi: 10.2196/15013. PubMed 31850847 ↗
  • Barger D, Leleux O, Conte V, Sapparrart V, Gapillout M, Crespel I, Erramouspe M, Delveaux S, Dabis F, Bonnet F. Integrating Electronic Patient-Reported Outcome Measures into Routine HIV Care and the ANRS CO3 Aquitaine Cohort's Data Capture and Visualization System (QuAliV): Protocol for a Formative Research Study. JMIR Res Protoc. 2018 Jun 7;7(6):e147. doi: 10.2196/resprot.9439. PubMed 29880467 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2017 (actual). Primary completion is estimated for Dec 2026, 113 months after the start.

Of 187 non-industry observational studies under HIV Infections, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 69. This study's planned 113 months is above that.

Counting every sponsor, half of 201 studies reached it within 38 months; a quarter within 16 and three quarters within 69.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 23, 2017
First posted
Sep 28, 2017
StartActual
Jul 18, 2017
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2026
Last update
Jul 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03296202
Collaborators
National Agency for Research on AIDS and Viral Hepatitis (ANRS), Institut National de la Santé Et de la Recherche Médicale, France, French Ministry of Health through the COREVIH Aquitaine
Responsible party
Sponsor
First posted
Sep 28, 2017
Start date
Jul 18, 2017
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jul 7, 2026

Study contacts

Linda WITTKOP, MD, PhD
study chair · ISPED - CHU de Bordeaux
Fabrice BONNET, Prof
principal investigator · University Hospital, Bordeaux

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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