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

September 3, 2021 updated by: University Hospital, Bordeaux

Risk of Morbidity, Mortality and Long-term Monitoring of Antiretroviral Treatment in People Living With HIV: The ANRS CO3 Aquitaine Cohort - AquiVIH-NA

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

7200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Agen, France, 47923
        • Recruiting
        • service de médecine interne - CH d'Agen
        • Contact:
        • Principal Investigator:
          • Patrick RISPAL, MD
      • Angoulême, France
        • Recruiting
        • Médecine interne - CH d'Angoulême
        • Principal Investigator:
          • Agnès RICHE, MD
      • Bayonne, France, 64109
        • Recruiting
        • service de maladies infectieuses - CH de la Côte Basque
        • Contact:
        • Principal Investigator:
          • Marc-Olivier VAREIL, MD
      • Bordeaux, France, 33075
        • Recruiting
        • service de médecine inter et maladies infectieuses - Hopital Saint André
        • Contact:
        • Principal Investigator:
          • Patrick MERCIE, Prof
      • Bordeaux, France, 33075
        • Recruiting
        • Service de Médecine Interne et maladies Infectieuses - Hôpital Saint-André
        • Contact:
        • Principal Investigator:
          • Fabrice BONNET, Prof
      • Bordeaux, France, 33076
        • Recruiting
        • service de maladies infectieuses et médecine tropicale - Hôpital Pellegrin
        • Contact:
        • Principal Investigator:
          • DUPON Michel, Prof
      • Bordeaux, France
        • Recruiting
        • Service D'Urgences Pédiatriques
        • Contact:
        • Principal Investigator:
          • Camille RUNEL-BELLIARD, MD
      • Châtellerault, France
        • Not yet recruiting
        • médecine interne - CH de Châtellerault
        • Contact:
        • Principal Investigator:
          • Antoine ELSENDOORN, MD
      • Dax, France, 40107
        • Recruiting
        • service de médecine interne et maladies infectieuses - CH de Dax
        • Contact:
        • Principal Investigator:
          • Yann GERARD, MD
      • Jonzac, France
        • Not yet recruiting
        • Médecine Interne - CH de Jonzac
        • Contact:
        • Principal Investigator:
          • Thierry PASDELOUP, MD
      • La Teste-de-Buch, France, 33260
        • Recruiting
        • service de médecine interne - CH d'Arcachon
        • Contact:
        • Principal Investigator:
          • Carine COURTAULT, MD
      • Libourne, France, 33505
        • Recruiting
        • service de médecine interne - CH de Libourne
        • Contact:
        • Sub-Investigator:
          • Sten DE WITTE, MD
        • Principal Investigator:
          • Helene FERRAND, MD
      • Mont-de-Marsan, France, 40024
        • Not yet recruiting
        • service de médecine interne - CH de Mont de Marsan
        • Contact:
        • Principal Investigator:
          • Hajnal-Gabriela ILLES, MD
      • Orthez, France
        • Recruiting
        • service de médecine interne - CH d'Orthez
        • Contact:
        • Principal Investigator:
          • Yann GERARD, MD
      • Pau, France, 64000
        • Recruiting
        • service de médecine interne et maladies infectieuses - CH de Pau
        • Contact:
        • Principal Investigator:
          • Eric MONLUN, MD
      • Perigueux, France, 24019
        • Recruiting
        • service de médecine interne et maladies infectieuses - CH de Périgueux
        • Contact:
        • Principal Investigator:
          • Philippe LATASTE, MD
      • Pessac, France
        • Recruiting
        • service de médecine interne et maladies infectieuses - Groupe hospitalier Sud
      • Poitiers, France
        • Recruiting
        • Médecine interne et Maladies Infectieuses - CHU de Poitiers
        • Contact:
        • Principal Investigator:
          • Gwenaël LE MOAL, MD
      • Royan, France
        • Not yet recruiting
        • Médecine interne - CH de Royan
        • Contact:
        • Principal Investigator:
          • Philippe MOTTAZ, MD
      • Saint-Jean-d'Angély, France
        • Not yet recruiting
        • Médecine Interne - CH de Saint-Jean-D'Angely
        • Principal Investigator:
          • Thierry PASDELOUP, MD
        • Contact:
      • Saintes, France
        • Not yet recruiting
        • Médecine Interne - CH de Saintonge
        • Principal Investigator:
          • Thierry PASDELOUP, MD
        • Contact:
      • Villeneuve sur Lot, France, 47307
        • Not yet recruiting
        • service de maladies infecteieuses - CH Saint-Cyr
        • Contact:
        • Principal Investigator:
          • Isabelle CHOSSAT, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients infected with HIV-1 (PLHIV)

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • HIV-2 infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
HIV patients
4500 patients infected with HIV-1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Socio-demographic characteristics of people living with the HIV
Time Frame: Each 12 months from baseline for 4 years (M48)
Each 12 months from baseline for 4 years (M48)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HIV infection characteristics of people living with the HIV
Time Frame: Each 12 months from baseline for 4 years (M48)
group of infection, stage of infection, duration since first serology positive, CD4 nadir, last CD4 measurement, CD4 / CD8 ratio
Each 12 months from baseline for 4 years (M48)
comorbidities of people living with the HIV
Time Frame: Each 12 months from baseline for 4 years (M48)
Each 12 months from baseline for 4 years (M48)
co-infections of people living with the HIV
Time Frame: Each 12 months from baseline for 4 years (M48)
Hepatitis B, Hepatitis C, cytomegalovirus infection...
Each 12 months from baseline for 4 years (M48)
Therapeutics description
Time Frame: Each 12 months from baseline for 4 years (M48)
naïve / treated status, dosage
Each 12 months from baseline for 4 years (M48)
virological responses
Time Frame: Each 12 months from baseline for 4 years (M48)
Each 12 months from baseline for 4 years (M48)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France
National Agency for Research on AIDS and Viral Hepatitis (ANRS)
French Ministry of Health through the COREVIH Aquitaine

Investigators

  • Study Chair: Linda WITTKOP, MD, PhD, ISPED - CHU de Bordeaux
  • Principal Investigator: Fabrice BONNET, Prof, University Hospital, Bordeaux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 18, 2017

Primary Completion (ANTICIPATED)

July 1, 2025

Study Completion (ANTICIPATED)

July 1, 2025

Study Registration Dates

First Submitted

June 23, 2017

First Submitted That Met QC Criteria

September 22, 2017

First Posted (ACTUAL)

September 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 5, 2021

Last Update Submitted That Met QC Criteria

September 3, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2016/04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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