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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV Infections, Antiretroviral Agents

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged over 18 years old. Confirmed HIV infection Signed informed consent Exclusion Criteria: HIV-2 infection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV patients<br>4500 patients infected with HIV-1 | |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, cohort studies, antiretroviral treatment