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

Recruiting

• Conditions: Antiretroviral Agents; HIV Infections

• Registration Number: NCT03296202
• Lead Sponsor: University Hospital, Bordeaux

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.

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 Timeline

• Study First Submitted: 2017-06-23
• Study Start: 2017-07-18
• Study First Submitted QC: 2017-09-22
• Study First Posted: 2017-09-28
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 7200

Inclusion Criteria

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

Exclusion Criteria

• HIV-2 infection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Socio-demographic characteristics of people living with the HIV	Each 12 months from baseline for 4 years (M48)

Secondary Outcome Measures

Name	Time	Method
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)	Hepatitis B, Hepatitis C, cytomegalovirus infection...
HIV infection characteristics of people living with the HIV	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
Therapeutics description	Each 12 months from baseline for 4 years (M48)	naïve / treated status, dosage
virological responses	Each 12 months from baseline for 4 years (M48)

Trial Locations

Locations (22)

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 de médecine inter et maladies infectieuses - Hopital Saint André; 🇫🇷 Bordeaux, France

service de médecine interne et maladies infectieuses - Hôpital Saint-André; 🇫🇷 Bordeaux, France

service de maladies infectieuses et médecine tropicale - Hôpital Pellegrin; 🇫🇷 Bordeaux, France

Service D'Urgences Pédiatriques; 🇫🇷 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

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