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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Argenteuil, France, 95100
      • Bobigny, France, 93000
      • Bordeaux, France, 33076
        • Recruiting
        • Hôpital 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
        • Hôpital 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
        • Hôpital 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
        • Hôpital Edouard Herriot
        • Contact:
          • Djamila MAKHLOUFI
      • Lyon, France
        • Recruiting
        • Hopital 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
        • Hôpital 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 salpètrière
        • Principal Investigator:
          • Roland Tubiana, MD
      • Paris, France, 75475
        • Recruiting
        • Hôpital 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
        • Hôpital André 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ANRS, Emerging Infectious Diseases

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 1994

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 8, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 8, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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