HIV-2 InfectionANRS CO VIH2NCT04658329
Cohorte Nationale VIH-2
An observational study of HIV-2 Infection, run by ANRS, Emerging Infectious Diseases at 29 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-2 Infection
- What is being tested?
- Antiretroviral
- How many people
- 1,185 participants
- Where
- 29 sitesFrance
- Study dates
- 1 Jan 1994to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV-2 infection only followed in consultation or hospitalization in one of the participating centers in France
Who may be able to join
- 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.
Who cannot join
- HIV-1 infection
- Double HIV-1 + HIV-2 seropositivity
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
France29 sites, 29 recruiting
- Recruiting
Centre hospitalier Victor Dupouy
Argenteuil, 95100
Philippe PG GENET, MD, +33.1.34.23.20.63, philippe.genet@ch-argenteuil.fr
Juliette JG GERBE, +33.1.34.23.22.18, juliette.gerbe@ch-argenteuil.fr
- Recruiting
Avicenne
Bobigny, 93000
Olivier OB BOUCHAUD, PhD, +33.1.48.95.54.21, olivier.bouchaud@aphp.fr
MOHAMED KASSIM MKY YOUSSOUF, MD, +33.1.48.95.71.94, mohamedkassim.youssouf@aphp.fr
- Recruiting
Hôpital Saint André
Bordeaux, 33076
Philippe Morlat, Pr
Philippe Morlat, Pr
- Recruiting
Service de Medecine Interne Hopital Antoine Beclere
Clamart, 92140
Francois Boue, MD, francois.boue@abc.ap-hop-paris.fr
Francois Boue, MD
- Recruiting
Hôpital Louis Mourier
Colombes, 92700
Emmanuel Mortier, MD
Emmanuel Mortier, MD
- Recruiting
Hôpital Sud Francilien
Corbeil-Essonnes, 91106
Amélie Chabrol, MD
- Recruiting
Hôpital Henri Mondor
Créteil, 94010
Jean-Daniel Lelievre, MD, PhD
Jean-Daniel Lelievre, MD, PhD
- Recruiting
Service de Médecine interne - Centre Hospitalier Intercommunal
Créteil, 94010
Valérie GARRAIT, MD
Valérie GARRAIT
- Recruiting
Hôpital Edouard Herriot
Lyon, 69437
Djamila MAKHLOUFI
- Recruiting
Hôpital de La Croix Rousse
Lyon
Laurent COTTE
Laurent COTTE
- Recruiting
Centre Hospitalier François Quesnay
Mantes-la-Jolie
Ahmed JABBAR
Ahmed JABBAR
- Recruiting
Hôpital Gui de Chaudiac
Montpellier, 34295
Jacques Reynes
- Recruiting
Hôpital de l'Hotel Dieu
Nantes, 44093
François RAFFI
- Recruiting
Hôpital Saint Louis
Paris, 75010
Jean-Michel Molina, Pr
Jean-Michel Molina, Pr
- Recruiting
Hôpital Saint Antoine
Paris, 75012
Marie Caroline Meyohas, Pr
- Recruiting
Hôpital la Pitié Salpétrière
Paris, 75013
Roland Tubiana, MD
- Recruiting
Service de Medecine Interne Hopital Cochin
Paris, 75014
Dominique Salmon, MD, dominique.salmon@cch.ap-hop-paris.fr
Dominique Salmon, MD
- Recruiting
Hôpital Bichat - Claude Bernard
Paris, 75018
Sophie Matheron, MD
- Recruiting
Hôpital Tenon
Paris, 75020
Pialloux Gilles, Pr, gilles.pialoux@tnn.aphp.fr
Gilles Pialloux, Pr
- Recruiting
Hôpital Hôtel Dieu
Paris, 75181
Jean-Paul Viard, MD
Jean-Paul Viard, MD
- Recruiting
Hôpital Lariboisière
Paris, 75475
Agathe Rami, Dr, agathe.rami@lrb.aphp.fr
Rami Agathe, Dr
- Recruiting
Hopital du Kremlin Bicêtre Service de médecine interne
Paris, 94275
Cécile Goujard, MD, +33 1 45 21 ext. 25 77, cecile.goujard@bct.aphp.fr
Cécile Goujard, MD
- Recruiting
Centre Hospitalier René Dubos
Pontoise, 95301
Laurent BLUM
- Recruiting
Hôpital Pontchaillou
Rennes, 35033
Cedric Arvieux, Dr, cedric.arvieux@chu-rennes.fr
Cedric Arvieux, Dr
- Recruiting
Hôpital Delafontaine
Saint-Denis, 93205
Marie-Aude KHUONG
- Recruiting
CHI Poissy Saint Germain en Laye
Saint-Germain-en-Laye, 78105
Yves Welker, MD
Yves Welker, MD
- Recruiting
Hôpital Bretonneau - Service des Maladies Infectieuses
Tours, 37044
Louis Bernard, PH
- Recruiting
Hôpital André Mignot
Versailles, 78157
Alix Greder-Belan, MD
Alix Greder-Belan, MD
- Recruiting
CHI Villeneuve Saint Georges
Villeneuve-Saint-Georges, 94195
Olivier Patey, MD, +33 (0)1 43 86 21 62
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV-2 Infection
- Being tested
- Antiretroviral
- Keywords
- virus, HIV, cohort
- Medical subject headings
- Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntiretroviralDrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Study HIV-2 infection rate in adult patients followed in France
Measured: At the baseline
Secondary outcomes (6)
The clinical progression of patients infected HIV-2 evaluate by samples: biological examinations
Every 6 months
Measured: Up to 25 years
The epidemiological parameters and progression of patients infected with HIV-2 evaluate by a questionnaire
Every 6 months
Measured: Up to 25 years
The rate of immuno-virological charge of the infection evaluate by serology samples
Every 6 months
Measured: Up to 25 years
Pourcentage of patient with HIV-2
The prognostic factors of patient evolution are evaluate by biological samples
Measured: Up to 25 years
Pourcentage of response to antiretroviral treatment evaluate by serology samples
Measured: Up to 25 years
Pourcentage of good management practices of patients followed in French hospitals evaluate by results
During the procedure
Measured: Up to 25 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start1 Jan 1994
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,185 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- François Dabis, Pr, MD, Study director, ANRS, Emerging Infectious Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04658329
- Sponsor's protocol ID
- ANRS CO5 VIH-2
- Acronym
- ANRS CO VIH2
- Status last verified
- Dec 2020
- First submitted
- 5 Aug 2020
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohorte ANRS CO5 "Cohorte Nationale VIH2"
- ClinicalTrials.gov ID
- NCT04658329
- Acronym / sponsor ID
- ANRS CO VIH2 / ANRS CO5 VIH-2
- Conditions
- HIV-2 Infection
- Keywords
- virus, HIV, cohort
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,185 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- 1 Jan 1994 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 8 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-2 infection only followed in consultation or hospitalization in one of the participating centers in France
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (2 listed)
- HIV-1 infection
- Double HIV-1 + HIV-2 seropositivity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntiretroviralStudy 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. | Drug | – |
Primary outcome
Study HIV-2 infection rate in adult patients followed in France
Time frame: At the baseline
6 secondary outcomes
The clinical progression of patients infected HIV-2 evaluate by samples: biological examinations
Time frame: 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
The rate of immuno-virological charge of the infection evaluate by serology samples
Time frame: Up to 25 years
Pourcentage of patient with HIV-2
Time frame: Up to 25 years
Pourcentage of response to antiretroviral treatment evaluate by serology samples
Time frame: Up to 25 years
Pourcentage of good management practices of patients followed in French hospitals evaluate by results
Time frame: Up to 25 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Dabis, Pr, MD study director
ANRS, Emerging Infectious Diseases
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-2 Infection, run by ANRS, Emerging Infectious Diseases at 29 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sophie Matheron, Pr, MD (01 40 25 72 39, sophie.matheron@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study HIV-2 infection rate in adult patients followed in France (time frame: At the baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2020.