Cohorte Nationale VIH-2 (ANRS CO VIH2)

December 1, 2020 updated by: ANRS, Emerging Infectious Diseases

Cohorte ANRS CO5 "Cohorte Nationale VIH2"

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

1185

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Argenteuil, France, 95100
      • Bobigny, France, 93000
      • Bordeaux, France, 33076
        • Recruiting
        • Hopital Saint André
        • Contact:
          • Philippe Morlat, Pr
        • Principal Investigator:
          • Philippe Morlat, Pr
      • Clamart, France, 92140
        • Recruiting
        • Service de Medecine Interne Hopital Antoine Beclere
        • Contact:
        • Principal Investigator:
          • Francois Boue, MD
      • Colombes, France, 92700
        • Recruiting
        • Hopital Louis Mourier
        • Contact:
          • Emmanuel Mortier, MD
        • Principal Investigator:
          • Emmanuel Mortier, MD
      • Corbeil-essonnes, France, 91106
        • Recruiting
        • Hôpital Sud Francilien
        • Principal Investigator:
          • Amélie Chabrol, MD
      • Creteil, France, 94010
        • Recruiting
        • Hopital Henri Mondor
        • Contact:
          • Jean-Daniel Lelievre, MD, PhD
        • Principal Investigator:
          • Jean-Daniel Lelievre, MD, PhD
      • Créteil, France, 94010
        • Recruiting
        • Service de Médecine interne - Centre Hospitalier Intercommunal
        • Principal Investigator:
          • Valérie Garrait
        • Contact:
          • Valérie GARRAIT, MD
      • Lyon, France, 69437
        • Recruiting
        • Hopital Edouard Herriot
        • Contact:
          • Djamila MAKHLOUFI
      • Lyon, France
        • Recruiting
        • Hôpital de la Croix Rousse
        • Contact:
          • Laurent COTTE
        • Principal Investigator:
          • Laurent COTTE
        • Sub-Investigator:
          • Jean-Marc LABAUNE
      • Mantes la Jolie, France
        • Recruiting
        • Centre Hospitalier François Quesnay
      • Montpellier, France, 34295
        • Recruiting
        • Hôpital Gui de Chaudiac
        • Contact:
          • Jacques Reynes
      • Nantes, France, 44093
        • Recruiting
        • Hôpital de l'Hôtel Dieu
        • Contact:
          • François RAFFI
      • Paris, France, 75010
        • Recruiting
        • Hopital Saint Louis
        • Principal Investigator:
          • Jean-Michel Molina, Pr
        • Contact:
          • Jean-Michel Molina, Pr
      • Paris, France, 75181
        • Recruiting
        • Hôpital Hôtel Dieu
        • Contact:
          • Jean-Paul Viard, MD
        • Principal Investigator:
          • Jean-Paul Viard, MD
      • Paris, France, 75012
        • Recruiting
        • Hôpital Saint Antoine
        • Contact:
          • Marie Caroline Meyohas, Pr
      • Paris, France, 75018
        • Recruiting
        • Hôpital Bichat - Claude Bernard
        • Principal Investigator:
          • Sophie Matheron, MD
      • Paris, France, 75020
        • Recruiting
        • Hopital Tenon
        • Contact:
        • Principal Investigator:
          • Gilles Pialloux, Pr
      • Paris, France, 75013
        • Recruiting
        • Hôpital La Pitié Salpêtrière
        • Principal Investigator:
          • Roland Tubiana, MD
      • Paris, France, 75475
        • Recruiting
        • Hopital Lariboisière
        • Contact:
        • Principal Investigator:
          • Rami Agathe, Dr
      • Paris, France, 75014
      • Paris, France, 94275
        • Recruiting
        • Hopital du Kremlin Bicêtre Service de médecine interne
        • Contact:
        • Principal Investigator:
          • Cécile Goujard, MD
      • Pontoise, France, 95301
        • Recruiting
        • Centre Hospitalier René Dubos
        • Contact:
          • Laurent BLUM
      • Rennes, France, 35033
        • Recruiting
        • Hôpital Pontchaillou
        • Contact:
        • Principal Investigator:
          • Cedric Arvieux, Dr
      • Saint Germain en Laye, France, 78105
        • Recruiting
        • CHI Poissy Saint Germain en Laye
        • Principal Investigator:
          • Yves Welker, MD
        • Contact:
          • Yves Welker, MD
      • Saint-Denis, France, 93205
        • Recruiting
        • Hopital DELAFONTAINE
        • Contact:
          • Marie-Aude KHUONG
      • Tours, France, 37044
        • Recruiting
        • Hôpital Bretonneau - Service des Maladies Infectieuses
        • Contact:
          • Louis Bernard, PH
      • Versailles, France, 78157
        • Recruiting
        • Hopital Andre Mignot
        • Contact:
          • Alix Greder-Belan, MD
        • Principal Investigator:
          • Alix Greder-Belan, MD
      • Villeneuve Saint Georges, France, 94195
        • Recruiting
        • CHI Villeneuve Saint Georges
        • Contact:
          • Olivier Patey, MD
          • Phone Number: +33 (0)1 43 86 21 62

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

HIV-2 infection only followed in consultation or hospitalization in one of the participating centers in France

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Study HIV-2 infection rate in adult patients followed in France
Time Frame: At the baseline
At the baseline

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ANRS, Emerging Infectious Diseases

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 1994

Primary Completion (Anticipated)

September 30, 2022

Study Completion (Anticipated)

September 30, 2022

Study Registration Dates

First Submitted

August 5, 2020

First Submitted That Met QC Criteria

December 1, 2020

First Posted (Actual)

December 8, 2020

Study Record Updates

Last Update Posted (Actual)

December 8, 2020

Last Update Submitted That Met QC Criteria

December 1, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANRS CO5 VIH-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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