NCT03296202

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
7,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Longer than P75 for all trials

Geographic Reach
1 country

24 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2017

Completed
25 days until next milestone

Study Start

First participant enrolled

July 18, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 28, 2017

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

February 21, 2025

Status Verified

February 1, 2025

Enrollment Period

8 years

First QC Date

June 23, 2017

Last Update Submit

February 19, 2025

Conditions

HIV InfectionsAntiretroviral Agents

Keywords

HIVcohort studiesantiretroviral treatment

Outcome Measures

Primary Outcomes (1)

  • Socio-demographic characteristics of people living with the HIV

    Each 12 months from baseline for 4 years (M48)

Secondary Outcomes (5)

  • HIV infection characteristics of people living with the HIV

    Each 12 months from baseline for 4 years (M48)

  • comorbidities of people living with the HIV

    Each 12 months from baseline for 4 years (M48)

  • co-infections of people living with the HIV

    Each 12 months from baseline for 4 years (M48)

  • Therapeutics description

    Each 12 months from baseline for 4 years (M48)

  • virological responses

    Each 12 months from baseline for 4 years (M48)

Study Arms (1)

HIV patients

7200 patients infected with HIV-1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients infected with HIV-1 (PLHIV)

You may qualify if:

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

You may not qualify if:

  • HIV-2 infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

service de médecine interne - CH d'Agen

Agen, 47923, France

RECRUITING

Médecine interne - CH d'Angoulême

Angoulême, France

RECRUITING

service de maladies infectieuses - CH de la Côte Basque

Bayonne, 64109, France

RECRUITING

service de médecine inter et maladies infectieuses - Hopital Saint André

Bordeaux, 33075, France

RECRUITING

service de médecine interne et maladies infectieuses - Hôpital Saint-André

Bordeaux, 33075, France

RECRUITING

service de maladies infectieuses et médecine tropicale - Hôpital Pellegrin

Bordeaux, 33076, France

RECRUITING

service de maladies infectieuses et médecine tropicale - Hôpital Pellegrin

Bordeaux, 33076, France

RECRUITING

service de maladies infectieuses et médecine tropicale - Hôpital Pellegrin

Bordeaux, 33076, France

RECRUITING

Service D'Urgences Pédiatriques

Bordeaux, France

RECRUITING

médecine interne - CH de Châtellerault

Châtellerault, France

NOT YET RECRUITING

service de médecine interne et maladies infectieuses - CH de Dax

Dax, 40107, France

RECRUITING

Médecine Interne - CH de Jonzac

Jonzac, France

RECRUITING

service de médecine interne - CH d'Arcachon

La Teste-de-Buch, 33260, France

RECRUITING

service de médecine interne - CH de Libourne

Libourne, 33505, France

RECRUITING

service de médecine interne - CH de Mont de Marsan

Mont-de-Marsan, 40024, France

NOT YET RECRUITING

service de médecine interne - CH d'Orthez

Orthez, France

RECRUITING

service de médecine interne et maladies infectieuses - CH de Pau

Pau, 64000, France

RECRUITING

service de médecine interne et maladies infectieuses - Groupe hospitalier Sud

Pessac, France

RECRUITING

service de médecine interne et maladies infectieuses - CH de Périgueux

Périgueux, 24019, France

RECRUITING

Médecine interne et Maladies Infectieuses - CHU de Poitiers

Poitiers, France

RECRUITING

Médecine interne - CH de Royan

Royan, France

RECRUITING

Médecine Interne - CH de Saint-Jean-D'Angely

Saint-Jean-d'Angély, France

RECRUITING

Médecine Interne - CH de Saintonge

Saintes, France

RECRUITING

service de maladies infecteieuses - CH Saint-Cyr

Villeneuve-sur-Lot, 47307, France

NOT YET RECRUITING

Related Publications (4)

  • 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.

    PMID: 36624391DERIVED

  • 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.

    PMID: 32650781DERIVED

  • 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.

    PMID: 31850847DERIVED

  • 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.

    PMID: 29880467DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood sampling

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Linda WITTKOP, MD, PhD

    ISPED - CHU de Bordeaux

    STUDY CHAIR

  • Fabrice BONNET, Prof

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabrice BONNET, Prof

CONTACT

(0)5 56 79 58 26fabrice.bonnet@chu-bordeaux.fr

Olivier LELEUX

CONTACT

(0)5 57 57 45 44Olivier.Leleux@u-bordeaux.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2017

First Posted

September 28, 2017

Study Start

July 18, 2017

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

February 21, 2025

Record last verified: 2025-02

Locations

FR(24)