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

NCT ID: NCT03296202

Last Updated: 2025-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

7200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-18

Study Completion Date

2025-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Infections Antiretroviral Agents

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HIV patients

7200 patients infected with HIV-1

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* HIV-2 infection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Agency for Research on AIDS and Viral Hepatitis (ANRS)

OTHER

Sponsor Role collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

French Ministry of Health through the COREVIH Aquitaine

UNKNOWN

Sponsor Role collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Linda WITTKOP, MD, PhD

Role: STUDY_CHAIR

ISPED - CHU de Bordeaux

Fabrice BONNET, Prof

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

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service de médecine interne - CH d'Agen

Agen, , France

Site Status RECRUITING

Médecine interne - CH d'Angoulême

Angoulême, , France

Site Status RECRUITING

service de maladies infectieuses - CH de la Côte Basque

Bayonne, , France

Site Status RECRUITING

service de médecine inter et maladies infectieuses - Hopital Saint André

Bordeaux, , France

Site Status RECRUITING

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

Bordeaux, , France

Site Status RECRUITING

service de maladies infectieuses et médecine tropicale - Hôpital Pellegrin

Bordeaux, , France

Site Status RECRUITING

service de maladies infectieuses et médecine tropicale - Hôpital Pellegrin

Bordeaux, , France

Site Status RECRUITING

service de maladies infectieuses et médecine tropicale - Hôpital Pellegrin

Bordeaux, , France

Site Status RECRUITING

Service D'Urgences Pédiatriques

Bordeaux, , France

Site Status RECRUITING

médecine interne - CH de Châtellerault

Châtellerault, , France

Site Status NOT_YET_RECRUITING

service de médecine interne et maladies infectieuses - CH de Dax

Dax, , France

Site Status RECRUITING

Médecine Interne - CH de Jonzac

Jonzac, , France

Site Status RECRUITING

service de médecine interne - CH d'Arcachon

La Teste-de-Buch, , France

Site Status RECRUITING

service de médecine interne - CH de Libourne

Libourne, , France

Site Status RECRUITING

service de médecine interne - CH de Mont de Marsan

Mont-de-Marsan, , France

Site Status NOT_YET_RECRUITING

service de médecine interne - CH d'Orthez

Orthez, , France

Site Status RECRUITING

service de médecine interne et maladies infectieuses - CH de Pau

Pau, , France

Site Status RECRUITING

service de médecine interne et maladies infectieuses - Groupe hospitalier Sud

Pessac, , France

Site Status RECRUITING

service de médecine interne et maladies infectieuses - CH de Périgueux

Périgueux, , France

Site Status RECRUITING

Médecine interne et Maladies Infectieuses - CHU de Poitiers

Poitiers, , France

Site Status RECRUITING

Médecine interne - CH de Royan

Royan, , France

Site Status RECRUITING

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

Saint-Jean-d'Angély, , France

Site Status RECRUITING

Médecine Interne - CH de Saintonge

Saintes, , France

Site Status RECRUITING

service de maladies infecteieuses - CH Saint-Cyr

Villeneuve-sur-Lot, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Fabrice BONNET, Prof

Role: CONTACT

(0)5 56 79 58 26 ext. +33

Olivier LELEUX

Role: CONTACT

(0)5 57 57 45 44 ext. +33

Facility Contacts

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Patrick RISPAL, MD

Role: primary

Agnès RICHE, MD

Role: primary

Marc-Olivier VAREIL, MD

Role: primary

Patrick MERCIE, Prof

Role: primary

Fabrice BONNET, Prof

Role: primary

MALVY Denis, Prof

Role: primary

Didier NEAU, Prof

Role: primary

DUPON Michel, Prof

Role: primary

Camille RUNEL-BELLIARD, MD

Role: primary

Antoine ELSENDOORN, MD

Role: primary

Yann GERARD, MD

Role: primary

Thierry PASDELOUP, MD

Role: primary

Carine COURTAULT, MD

Role: primary

Helene FERRAND, MD

Role: primary

Hajnal-Gabriela ILLES, MD

Role: primary

Yann GERARD, MD

Role: primary

Eric MONLUN, MD

Role: primary

Jean-François VIALLARD, Prof

Role: primary

Philippe LATASTE, MD

Role: primary

Gwenaël LE MOAL, MD

Role: primary

Philippe MOTTAZ, MD

Role: primary

Thierry PASDELOUP, MD

Role: primary

Thierry PASDELOUP, MD

Role: primary

Isabelle CHOSSAT, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 36624391 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32650781 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31850847 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29880467 (View on PubMed)

Other Identifiers

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CHUBX 2016/04

Identifier Type: -

Identifier Source: org_study_id

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