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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03296202
Acronym
AquiVIH-NA
Enrollment
7500
Registered
2017-09-28
Start date
2017-07-18
Completion date
2026-12-01
Last updated
2026-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antiretroviral Agents, HIV Infections

Keywords

HIV, cohort studies, antiretroviral treatment

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.

Interventions

None listed

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* HIV-2 infection

Design outcomes

Primary

MeasureTime frame
Socio-demographic characteristics of people living with the HIVEach 12 months from baseline for 4 years (M48)

Secondary

MeasureTime frameDescription
HIV infection characteristics of people living with the HIVEach 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
comorbidities of people living with the HIVEach 12 months from baseline for 4 years (M48)
co-infections of people living with the HIVEach 12 months from baseline for 4 years (M48)Hepatitis B, Hepatitis C, cytomegalovirus infection...
Therapeutics descriptionEach 12 months from baseline for 4 years (M48)naïve / treated status, dosage
virological responsesEach 12 months from baseline for 4 years (M48)

Countries

France

Contacts

STUDY_CHAIRLinda WITTKOP, MD, PhD

ISPED - CHU de Bordeaux

PRINCIPAL_INVESTIGATORFabrice BONNET, Prof

University Hospital, Bordeaux

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 8, 2026