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Active, Not Recruiting

NCT Number: NCT03296202

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

service de médecine interne - CH d'Agen, Agen, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • HIV-2 infection

Treatment and study plan

Primary outcomes

  1. Socio-demographic characteristics of people living with the HIV

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

Secondary outcomes

  1. HIV infection characteristics of people living with the HIV

    Time frame: 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

  2. comorbidities of people living with the HIV

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

  3. co-infections of people living with the HIV

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

    Hepatitis B, Hepatitis C, cytomegalovirus infection...

  4. Therapeutics description

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

    naïve / treated status, dosage

  5. virological responses

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

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • 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)

Registry information

Official study title

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

Acronym: AquiVIH-NA

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Sep 28, 2017
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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