NCT04658329

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,185

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1994

Longer than P75 for all trials

Geographic Reach
1 country

29 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1994

Completed
26.6 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 8, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

December 8, 2020

Status Verified

December 1, 2020

Enrollment Period

28.8 years

First QC Date

August 5, 2020

Last Update Submit

December 1, 2020

Conditions

Keywords

virusHIVcohort

Outcome Measures

Primary Outcomes (1)

  • Study HIV-2 infection rate in adult patients followed in France

    At the baseline

Secondary Outcomes (6)

  • The clinical progression of patients infected HIV-2 evaluate by samples: biological examinations

    Up to 25 years

  • The epidemiological parameters and progression of patients infected with HIV-2 evaluate by a questionnaire

    Up to 25 years

  • The rate of immuno-virological charge of the infection evaluate by serology samples

    Up to 25 years

  • Pourcentage of patient with HIV-2

    Up to 25 years

  • Pourcentage of response to antiretroviral treatment evaluate by serology samples

    Up to 25 years

  • +1 more secondary outcomes

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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,

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

Centre hospitalier Victor Dupouy

Argenteuil, 95100, France

RECRUITING

Avicenne

Bobigny, 93000, France

RECRUITING

Hôpital Saint André

Bordeaux, 33076, France

RECRUITING

Service de Medecine Interne Hopital Antoine Beclere

Clamart, 92140, France

RECRUITING

Hôpital Louis Mourier

Colombes, 92700, France

RECRUITING

Hôpital Sud Francilien

Corbeil-Essonnes, 91106, France

RECRUITING

Hôpital Henri Mondor

Créteil, 94010, France

RECRUITING

Service de Médecine interne - Centre Hospitalier Intercommunal

Créteil, 94010, France

RECRUITING

Hôpital Edouard Herriot

Lyon, 69437, France

RECRUITING

Hôpital de La Croix Rousse

Lyon, France

RECRUITING

Centre Hospitalier François Quesnay

Mantes-la-Jolie, France

RECRUITING

Hôpital Gui de Chaudiac

Montpellier, 34295, France

RECRUITING

Hôpital de l'Hotel Dieu

Nantes, 44093, France

RECRUITING

Hôpital Saint Louis

Paris, 75010, France

RECRUITING

Hôpital Saint Antoine

Paris, 75012, France

RECRUITING

Hôpital la Pitié Salpétrière

Paris, 75013, France

RECRUITING

Service de Medecine Interne Hopital Cochin

Paris, 75014, France

RECRUITING

Hôpital Bichat - Claude Bernard

Paris, 75018, France

RECRUITING

Hôpital Tenon

Paris, 75020, France

RECRUITING

Hôpital Hôtel Dieu

Paris, 75181, France

RECRUITING

Hôpital Lariboisière

Paris, 75475, France

RECRUITING

Hopital du Kremlin Bicêtre Service de médecine interne

Paris, 94275, France

RECRUITING

Centre Hospitalier René Dubos

Pontoise, 95301, France

RECRUITING

Hôpital Pontchaillou

Rennes, 35033, France

RECRUITING

Hôpital Delafontaine

Saint-Denis, 93205, France

RECRUITING

CHI Poissy Saint Germain en Laye

Saint-Germain-en-Laye, 78105, France

RECRUITING

Hôpital Bretonneau - Service des Maladies Infectieuses

Tours, 37044, France

RECRUITING

Hôpital André Mignot

Versailles, 78157, France

RECRUITING

CHI Villeneuve Saint Georges

Villeneuve-Saint-Georges, 94195, France

RECRUITING

MeSH Terms

Conditions

Virus Diseases

Interventions

Anti-Retroviral Agents

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Antiviral AgentsAnti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • François Dabis, Pr, MD

    ANRS, Emerging Infectious Diseases

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2020

First Posted

December 8, 2020

Study Start

January 1, 1994

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

December 8, 2020

Record last verified: 2020-12

Locations