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ANRS CO VIH2: Cohorte Nationale VIH-2

Sponsor
ANRS, Emerging Infectious Diseases (Other)
Overall Status
Recruiting
CT.gov ID
NCT04658329
Collaborator
(none)
1,185
Enrollment
29
Locations
344.9
Anticipated Duration (Months)
40.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
1185 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Cohorte ANRS CO5 "Cohorte Nationale VIH2"
Actual Study Start Date :
Jan 1, 1994
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Outcome Measures

Primary Outcome Measures

  1. Study HIV-2 infection rate in adult patients followed in France [At the baseline]

Secondary Outcome Measures

  1. The clinical progression of patients infected HIV-2 evaluate by samples: biological examinations [Up to 25 years]

    Every 6 months

  2. The epidemiological parameters and progression of patients infected with HIV-2 evaluate by a questionnaire [Up to 25 years]

    Every 6 months

  3. The rate of immuno-virological charge of the infection evaluate by serology samples [Up to 25 years]

    Every 6 months

  4. Pourcentage of patient with HIV-2 [Up to 25 years]

    The prognostic factors of patient evolution are evaluate by biological samples

  5. Pourcentage of response to antiretroviral treatment evaluate by serology samples [Up to 25 years]

  6. Pourcentage of good management practices of patients followed in French hospitals evaluate by results [Up to 25 years]

    During the procedure

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre hospitalier Victor Dupouy Argenteuil France 95100
2 Avicenne Bobigny France 93000
3 Hôpital Saint André Bordeaux France 33076
4 Service de Medecine Interne Hopital Antoine Beclere Clamart France 92140
5 Hôpital Louis Mourier Colombes France 92700
6 Hôpital Sud Francilien Corbeil-essonnes France 91106
7 Hôpital Henri Mondor Creteil France 94010
8 Service de Médecine interne - Centre Hospitalier Intercommunal Créteil France 94010
9 Hôpital Edouard Herriot Lyon France 69437
10 Hôpital de La Croix Rousse Lyon France
11 Centre Hospitalier François Quesnay Mantes la Jolie France
12 Hôpital Gui de Chaudiac Montpellier France 34295
13 Hôpital de l'Hotel Dieu Nantes France 44093
14 Hôpital Saint Louis Paris France 75010
15 Hôpital Saint Antoine Paris France 75012
16 Hôpital la Pitié Salpétrière Paris France 75013
17 Service de Medecine Interne Hopital Cochin Paris France 75014
18 Hôpital Bichat - Claude Bernard Paris France 75018
19 Hôpital Tenon Paris France 75020
20 Hôpital Hôtel Dieu Paris France 75181
21 Hôpital Lariboisière Paris France 75475
22 Hopital du Kremlin Bicêtre Service de médecine interne Paris France 94275
23 Centre Hospitalier René Dubos Pontoise France 95301
24 Hôpital Pontchaillou Rennes France 35033
25 CHI Poissy Saint Germain en Laye Saint Germain en Laye France 78105
26 Hôpital Delafontaine Saint-Denis France 93205
27 Hôpital Bretonneau - Service des Maladies Infectieuses Tours France 37044
28 Hôpital André Mignot Versailles France 78157
29 CHI Villeneuve Saint Georges Villeneuve Saint Georges France 94195

Sponsors and Collaborators

  • ANRS, Emerging Infectious Diseases

Investigators

  • Study Director: François Dabis, Pr, MD, ANRS, Emerging Infectious Diseases

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ANRS, Emerging Infectious Diseases
ClinicalTrials.gov Identifier:
NCT04658329
Other Study ID Numbers:
  • ANRS CO5 VIH-2
First Posted:
Dec 8, 2020
Last Update Posted:
Dec 8, 2020
Last Verified:
Dec 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by ANRS, Emerging Infectious Diseases
virus
HIV
cohort
Additional relevant MeSH terms:
Anti-Retroviral Agents

Study Results

No Results Posted as of Dec 8, 2020