Cohorte Nationale VIH-2

HIV-2 Infection Clinical Trial

— ANRS CO VIH2  

Official title:

Cohorte ANRS CO5 "Cohorte Nationale VIH2"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04658329
• Other study ID #: ANRS CO5 VIH-2
• Status: Recruiting
• Start date: January 1, 1994
• Est. completion date: September 30, 2022

Study information

• Verified date: December 2020
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: Sophie Matheron, Pr, MD
• Phone: 01 40 25 72 39
• Email: sophie.matheron[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1185
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV-2 Infection

Intervention

Drug:
• Antiretroviral
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.

Locations

Country	Name	City	State
France	Centre hospitalier Victor Dupouy	Argenteuil
France	Avicenne	Bobigny
France	Hôpital Saint André	Bordeaux
France	Service de Medecine Interne Hopital Antoine Beclere	Clamart
France	Hôpital Louis Mourier	Colombes
France	Hôpital Sud Francilien	Corbeil-essonnes
France	Hôpital Henri Mondor	Creteil
France	Service de Médecine interne - Centre Hospitalier Intercommunal	Créteil
France	Hôpital de La Croix Rousse	Lyon
France	Hôpital Edouard Herriot	Lyon
France	Centre Hospitalier François Quesnay	Mantes la Jolie
France	Hôpital Gui de Chaudiac	Montpellier
France	Hôpital de l'Hotel Dieu	Nantes
France	Hôpital Bichat - Claude Bernard	Paris
France	Hopital du Kremlin Bicêtre Service de médecine interne	Paris
France	Hôpital Hôtel Dieu	Paris
France	Hôpital la Pitié Salpétrière	Paris
France	Hôpital Lariboisière	Paris
France	Hôpital Saint Antoine	Paris
France	Hôpital Saint Louis	Paris
France	Hôpital Tenon	Paris
France	Service de Medecine Interne Hopital Cochin	Paris
France	Centre Hospitalier René Dubos	Pontoise
France	Hôpital Pontchaillou	Rennes
France	CHI Poissy Saint Germain en Laye	Saint Germain en Laye
France	Hôpital Delafontaine	Saint-Denis
France	Hôpital Bretonneau - Service des Maladies Infectieuses	Tours
France	Hôpital André Mignot	Versailles
France	CHI Villeneuve Saint Georges	Villeneuve Saint Georges

Sponsors (1)

Lead Sponsor	Collaborator
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study HIV-2 infection rate in adult patients followed in France		At the baseline
Secondary	The clinical progression of patients infected HIV-2 evaluate by samples: biological examinations	Every 6 months	Up to 25 years
Secondary	The epidemiological parameters and progression of patients infected with HIV-2 evaluate by a questionnaire	Every 6 months	Up to 25 years
Secondary	The rate of immuno-virological charge of the infection evaluate by serology samples	Every 6 months	Up to 25 years
Secondary	Pourcentage of patient with HIV-2	The prognostic factors of patient evolution are evaluate by biological samples	Up to 25 years
Secondary	Pourcentage of response to antiretroviral treatment evaluate by serology samples		Up to 25 years
Secondary	Pourcentage of good management practices of patients followed in French hospitals evaluate by results	During the procedure	Up to 25 years