Cohorte Nationale VIH-2

NCT04658329 — Unknown, 1185 participants, ANRS, Emerging Infectious Diseases

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Cohorte ANRS CO5 "Cohorte Nationale VIH2"

RegistryNCT04658329, acronym ANRS CO VIH2
StatusUnknown
Study typeObservational
Enrollment1185 (Estimated)
SponsorANRS, Emerging Infectious Diseases (Other gov)
ConditionsHIV-2 Infection
InterventionsAntiretroviral (Drug)
Datesstart 1994-01-01, primary completion 2022-09-30 (estimated), completion 2022-09-30 (estimated), first posted 2020-12-08, last updated 2020-12-08
Locations29 sites in France

Related Papers Related Patents Related Grants Related Experts
All trials for HIV-2 Infection All trials of Antiretroviral

-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.

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+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.

+Arms and interventions

  • Antiretroviral (Drug): 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.

+Outcome measures

Primary outcomes

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

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (29)

FacilityCityCountryStatus
Centre hospitalier Victor DupouyArgenteuilFranceRecruiting
AvicenneBobignyFranceRecruiting
Hôpital Saint AndréBordeauxFranceRecruiting
Service de Medecine Interne Hopital Antoine BeclereClamartFranceRecruiting
Hôpital Louis MourierColombesFranceRecruiting
Hôpital Sud FrancilienCorbeil-EssonnesFranceRecruiting
Hôpital Henri MondorCréteilFranceRecruiting
Service de Médecine interne - Centre Hospitalier IntercommunalCréteilFranceRecruiting
Hôpital Edouard HerriotLyonFranceRecruiting
Hôpital de La Croix RousseLyonFranceRecruiting
Centre Hospitalier François QuesnayMantes-la-JolieFranceRecruiting
Hôpital Gui de ChaudiacMontpellierFranceRecruiting
Hôpital de l'Hotel DieuNantesFranceRecruiting
Hôpital Saint LouisParisFranceRecruiting
Hôpital Saint AntoineParisFranceRecruiting
Hôpital la Pitié SalpétrièreParisFranceRecruiting
Service de Medecine Interne Hopital CochinParisFranceRecruiting
Hôpital Bichat - Claude BernardParisFranceRecruiting
Hôpital TenonParisFranceRecruiting
Hôpital Hôtel DieuParisFranceRecruiting
Hôpital LariboisièreParisFranceRecruiting
Hopital du Kremlin Bicêtre Service de médecine interneParisFranceRecruiting
Centre Hospitalier René DubosPontoiseFranceRecruiting
Hôpital PontchaillouRennesFranceRecruiting
Hôpital DelafontaineSaint-DenisFranceRecruiting
CHI Poissy Saint Germain en LayeSaint-Germain-en-LayeFranceRecruiting
Hôpital Bretonneau - Service des Maladies InfectieusesToursFranceRecruiting
Hôpital André MignotVersaillesFranceRecruiting
CHI Villeneuve Saint GeorgesVilleneuve-Saint-GeorgesFranceRecruiting

+Investigators

  • François Dabis, Pr, MD, Study director, ANRS, Emerging Infectious Diseases