Clinical trial NCT03296202: Risk of Morbidity, Mortality and Long-term Monitoring of Antiretroviral Treatment in People Living With HIV
Official title: Risk of Morbidity, Mortality and Long-term Monitoring of Antiretroviral Treatment in People Living With HIV: The ANRS CO3 Aquitaine Cohort - AquiVIH-NA
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV Infections
Antiretroviral Agents
Keywords: HIV
cohort studies
antiretroviral treatment
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: National Agency for Research on AIDS and Viral Hepatitis (ANRS)
name: Institut National de la Santé Et de la Recherche Médicale, France
name: French Ministry of Health through the COREVIH Aquitaine
First posted: 2017-09-28
Enrollment: 7200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients infected with HIV-1 (PLHIV)

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* HIV-2 infection

Primary outcomes:
measure: Socio-demographic characteristics of people living with the HIV
timeFrame: Each 12 months from baseline for 4 years (M48)
Secondary outcomes:
measure: HIV infection characteristics of people living with the HIV
timeFrame: Each 12 months from baseline for 4 years (M48)
measure: comorbidities of people living with the HIV
timeFrame: Each 12 months from baseline for 4 years (M48)
measure: co-infections of people living with the HIV
timeFrame: Each 12 months from baseline for 4 years (M48)
measure: Therapeutics description
timeFrame: Each 12 months from baseline for 4 years (M48)
measure: virological responses
timeFrame: Each 12 months from baseline for 4 years (M48)
Other outcomes:
Locations:
city: Agen
country: France
facility: service de médecine interne - CH d'Agen
city: Angoulême
country: France
facility: Médecine interne - CH d'Angoulême
city: Bayonne
country: France
facility: service de maladies infectieuses - CH de la Côte Basque
city: Bordeaux
country: France
facility: service de médecine inter et maladies infectieuses - Hopital Saint André
city: Bordeaux
country: France
facility: service de médecine interne et maladies infectieuses - Hôpital Saint-André
city: Bordeaux
country: France
facility: service de maladies infectieuses et médecine tropicale - Hôpital Pellegrin
city: Bordeaux
country: France
facility: service de maladies infectieuses et médecine tropicale - Hôpital Pellegrin
city: Bordeaux
country: France
facility: service de maladies infectieuses et médecine tropicale - Hôpital Pellegrin
city: Bordeaux
country: France
facility: Service D'Urgences Pédiatriques
city: Châtellerault
country: France
facility: médecine interne - CH de Châtellerault
city: Dax
country: France
facility: service de médecine interne et maladies infectieuses - CH de Dax
city: Jonzac
country: France
facility: Médecine Interne - CH de Jonzac
city: La Teste-de-Buch
country: France
facility: service de médecine interne - CH d'Arcachon
city: Libourne
country: France
facility: service de médecine interne - CH de Libourne
city: Mont-de-Marsan
country: France
facility: service de médecine interne - CH de Mont de Marsan
city: Orthez
country: France
facility: service de médecine interne - CH d'Orthez
city: Pau
country: France
facility: service de médecine interne et maladies infectieuses - CH de Pau
city: Perigueux
country: France
facility: service de médecine interne et maladies infectieuses - CH de Périgueux
city: Pessac
country: France
facility: service de médecine interne et maladies infectieuses - Groupe hospitalier Sud
city: Poitiers
country: France
facility: Médecine interne et Maladies Infectieuses - CHU de Poitiers
city: Royan
country: France
facility: Médecine interne - CH de Royan
city: Saint-Jean-d'Angély
country: France
facility: Médecine Interne - CH de Saint-Jean-D'Angely
city: Saintes
country: France
facility: Médecine Interne - CH de Saintonge
city: Villeneuve sur Lot
country: France
facility: service de maladies infecteieuses - CH Saint-Cyr
Study officials:
affiliation: ISPED - CHU de Bordeaux
name: Linda WITTKOP, MD, PhD
role: STUDY_CHAIR
affiliation: University Hospital, Bordeaux
name: Fabrice BONNET, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barger D, Hessamfar M, Neau D, Vareil MO, Lazaro E, Duffau P, Rouanes N, Leleux O, Le Marec F, Erramouspe M, Wittkop L, Dabis F, Bonnet F. Assessing the psychometric properties of the French WHOQOL-HIV BREF within the ANRS CO3 Aquitaine Cohort's QuAliV ancillary study. Health Qual Life Outcomes. 2020 Jul 10;18(1):220. doi: 10.1186/s12955-020-01451-8.
citation: Barger D, Leleux O, Conte V, Sapparrart V, Gapillout M, Crespel I, Erramouspe M, Delveaux S, Wittkop L, Dabis F, Bonnet F. Web-Based Module for the Collection of Electronic Patient-Reported Outcomes in People Living With HIV in Nouvelle Aquitaine, France: Usability Evaluation. JMIR Form Res. 2019 Dec 18;3(4):e15013. doi: 10.2196/15013.
citation: Barger D, Leleux O, Conte V, Sapparrart V, Gapillout M, Crespel I, Erramouspe M, Delveaux S, Dabis F, Bonnet F. Integrating Electronic Patient-Reported Outcome Measures into Routine HIV Care and the ANRS CO3 Aquitaine Cohort's Data Capture and Visualization System (QuAliV): Protocol for a Formative Research Study. JMIR Res Protoc. 2018 Jun 7;7(6):e147. doi: 10.2196/resprot.9439.