Clinical trial NCT04658329: Cohorte Nationale VIH-2
Official title: Cohorte ANRS CO5 "Cohorte Nationale VIH2"
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV-2 Infection
Keywords: virus
HIV
cohort
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
First posted: 2020-12-08
Enrollment: 1185
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: HIV-2 infection only followed in consultation or hospitalization in one of the participating centers in France

Brief summary: The HIV2 study is an open cohort of prospective, multicentric, national observation. The main objective is to study HIV-2 infection in adult patients followed in France.

Detailed description: The secondary objectives are :

* Describe the epidemiological and clinical characteristics of participants infected with HIV-2, and the immuno-virological characteristics of the infection.
* To study the clinical and immunological progression of HIV-2 infection and the prognostic factors of this evolution.
* Study the response to antiretroviral treatment (clinical, immuno-virological) and contribute to the identification of the antiretroviral strategies and combinations most suited to the particularities of the infection.
* Allow an evaluation of the care practices of participants followed in French hospitals
* Provide a bank of clinical-biological data and samples allowing the performance of virological and / or immunological studies on HIV-2 infection.

The follow-up of the participants is different according to the therapeutic status of the participants, naive of antiretroviral treatment or already treated with antiretrovirals.

Eligibility criteria: Inclusion Criteria:

* HIV-2 infection only, diagnosed by ELISA, confirmed by Western-Blot test,
* Follow-up in consultation or hospitalization in one of the investigating centers,
* Age greater than or equal to 18 years,
* Prolonged follow-up possible, residence in France planned for at least one year,
* Consent to participate,
* Long-term medical care possible for the participant, or by medical aid (AME), or declaration of obtaining AME at the time of inclusion.

Exclusion Criteria:

* HIV-1 infection
* Double HIV-1 + HIV-2 seropositivity

Primary outcomes:
measure: Study HIV-2 infection rate in adult patients followed in France
timeFrame: At the baseline
Secondary outcomes:
measure: The clinical progression of patients infected HIV-2 evaluate by samples: biological examinations
timeFrame: Up to 25 years
measure: The epidemiological parameters and progression of patients infected with HIV-2 evaluate by a questionnaire
timeFrame: Up to 25 years
measure: The rate of immuno-virological charge of the infection evaluate by serology samples
timeFrame: Up to 25 years
measure: Pourcentage of patient with HIV-2
timeFrame: Up to 25 years
measure: Pourcentage of response to antiretroviral treatment evaluate by serology samples
timeFrame: Up to 25 years
measure: Pourcentage of good management practices of patients followed in French hospitals evaluate by results
timeFrame: Up to 25 years
Other outcomes:
Locations:
city: Argenteuil
country: France
facility: Centre hospitalier Victor Dupouy
city: Bobigny
country: France
facility: Avicenne
city: Bordeaux
country: France
facility: Hôpital Saint André
city: Clamart
country: France
facility: Service de Medecine Interne Hopital Antoine Beclere
city: Colombes
country: France
facility: Hôpital Louis Mourier
city: Corbeil-essonnes
country: France
facility: Hôpital Sud Francilien
city: Creteil
country: France
facility: Hôpital Henri Mondor
city: Créteil
country: France
facility: Service de Médecine interne - Centre Hospitalier Intercommunal
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Lyon
country: France
facility: Hôpital de La Croix Rousse
city: Mantes la Jolie
country: France
facility: Centre Hospitalier François Quesnay
city: Montpellier
country: France
facility: Hôpital Gui de Chaudiac
city: Nantes
country: France
facility: Hôpital de l'Hotel Dieu
city: Paris
country: France
facility: Hôpital Saint Louis
city: Paris
country: France
facility: Hôpital Saint Antoine
city: Paris
country: France
facility: Hôpital la Pitié Salpétrière
city: Paris
country: France
facility: Service de Medecine Interne Hopital Cochin
city: Paris
country: France
facility: Hôpital Bichat - Claude Bernard
city: Paris
country: France
facility: Hôpital Tenon
city: Paris
country: France
facility: Hôpital Hôtel Dieu
city: Paris
country: France
facility: Hôpital Lariboisière
city: Paris
country: France
facility: Hopital du Kremlin Bicêtre Service de médecine interne
city: Pontoise
country: France
facility: Centre Hospitalier René Dubos
city: Rennes
country: France
facility: Hôpital Pontchaillou
city: Saint Germain en Laye
country: France
facility: CHI Poissy Saint Germain en Laye
city: Saint-Denis
country: France
facility: Hôpital Delafontaine
city: Tours
country: France
facility: Hôpital Bretonneau - Service des Maladies Infectieuses
city: Versailles
country: France
facility: Hôpital André Mignot
city: Villeneuve Saint Georges
country: France
facility: CHI Villeneuve Saint Georges
Study officials:
affiliation: ANRS, Emerging Infectious Diseases
name: François Dabis, Pr, MD
role: STUDY_DIRECTOR
References: