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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

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.

02

Conditions studied

  • HIV Infections
  • Antiretroviral Agents

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Keywords

  • HIV
  • cohort studies
  • antiretroviral treatment
03

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)

Inclusion criteria

  • Patients aged over 18 years old.
  • Confirmed HIV infection
  • Signed informed consent

Exclusion criteria

Exclusion Criteria:

  • HIV-2 infection
04

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

05

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)

06

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
07

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 ↗
08

Registry details

Key details

Study ID
NCT03296202
Lead sponsor
University Hospital, Bordeaux
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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