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NCT03296202 Clinical Trial

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

HIV Infections Clinical Trial

— AquiVIH-NA  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03296202
Other study ID # CHUBX 2016/04
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 18, 2017
Est. completion date July 2025

Study information
Verified date September 2021
Source University Hospital, Bordeaux
Contact Fabrice BONNET, Prof
Phone (0)5 56 79 58 26
Email fabrice.bonnet@chu-bordeaux.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 7200
Est. completion date July 2025
Est. primary completion date July 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients aged over 18 years old. - Confirmed HIV infection - Signed informed consent Exclusion Criteria: - HIV-2 infection

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France service de médecine interne - CH d'Agen Agen
France Médecine interne - CH d'Angoulême Angoulême
France service de maladies infectieuses - CH de la Côte Basque Bayonne
France Service D'Urgences Pédiatriques Bordeaux
France service de maladies infectieuses et médecine tropicale - Hôpital Pellegrin Bordeaux
France service de maladies infectieuses et médecine tropicale - Hôpital Pellegrin Bordeaux
France service de maladies infectieuses et médecine tropicale - Hôpital Pellegrin Bordeaux
France service de médecine inter et maladies infectieuses - Hopital Saint André Bordeaux
France service de médecine interne et maladies infectieuses - Hôpital Saint-André Bordeaux
France médecine interne - CH de Châtellerault Châtellerault
France service de médecine interne et maladies infectieuses - CH de Dax Dax
France Médecine Interne - CH de Jonzac Jonzac
France service de médecine interne - CH d'Arcachon La Teste-de-Buch
France service de médecine interne - CH de Libourne Libourne
France service de médecine interne - CH de Mont de Marsan Mont-de-Marsan
France service de médecine interne - CH d'Orthez Orthez
France service de médecine interne et maladies infectieuses - CH de Pau Pau
France service de médecine interne et maladies infectieuses - CH de Périgueux Perigueux
France service de médecine interne et maladies infectieuses - Groupe hospitalier Sud Pessac
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 service de maladies infecteieuses - CH Saint-Cyr Villeneuve sur Lot

Sponsors (4)
Lead Sponsor Collaborator
University Hospital, Bordeaux French Ministry of Health through the COREVIH Aquitaine, Institut National de la Santé Et de la Recherche Médicale, France, National Agency for Research on AIDS and Viral Hepatitis (ANRS)

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Socio-demographic characteristics of people living with the HIV Each 12 months from baseline for 4 years (M48)
Secondary 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 Each 12 months from baseline for 4 years (M48)
Secondary comorbidities of people living with the HIV Each 12 months from baseline for 4 years (M48)
Secondary co-infections of people living with the HIV Hepatitis B, Hepatitis C, cytomegalovirus infection... Each 12 months from baseline for 4 years (M48)
Secondary Therapeutics description naïve / treated status, dosage Each 12 months from baseline for 4 years (M48)
Secondary virological responses Each 12 months from baseline for 4 years (M48)
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