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Clinical Trials/NCT03296202
NCT03296202
Recruiting
Not Applicable

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

University Hospital, Bordeaux22 sites in 1 country7,200 target enrollmentJuly 18, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV Infections
Sponsor
University Hospital, Bordeaux
Enrollment
7200
Locations
22
Primary Endpoint
Socio-demographic characteristics of people living with the HIV
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 18, 2017
End Date
July 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Bordeaux
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • HIV-2 infection

Outcomes

Primary Outcomes

Socio-demographic characteristics of people living with the HIV

Time Frame: Each 12 months from baseline for 4 years (M48)

Secondary Outcomes

  • virological responses(Each 12 months from baseline for 4 years (M48))
  • 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))
  • HIV infection characteristics of people living with the HIV(Each 12 months from baseline for 4 years (M48))
  • Therapeutics description(Each 12 months from baseline for 4 years (M48))

Study Sites (22)

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