Status:
UNKNOWN
ANRS CO24 OncoVIHAC (Onco VIH Anti Checkpoint)
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Collaborating Sponsors:
Pitié-Salpêtrière Hospital
Bicetre Hospital
Conditions:
HIV Infected Patients With Cancer Treated by ICPi
Eligibility:
All Genders
18+ years
Brief Summary
A Multicenter, Observational, National Cohort for HIV Infected Patients with a Cancer treated by Immune-Checkpoint Inhibitors (ICPi) for less than one month or to be treated with an ICPi such as anti-...
Detailed Description
Primary Objective To evaluate clinical and biological safety of the use of immune checkpoint inhibitors in HIV infected patients with cancer treated by Immune-Checkpoint Inhibitors (ICPi). Secondary ...
Eligibility Criteria
Inclusion
- Study Population for Cohort
- Inclusion criteria :
- Age ≥ 18 years
- Documented HIV-1 infection treated or untreated with antiretrovirals
- Cancer histologically and /or cytologically proven
- Person treated for less than 30 days or who should be treated with anti-PD-1 or anti-PDL-1 or anti-CTLA4 according to current recommendations
- Signed informed consent
- Exclusion Criteria
- \- Subject participating in clinical trials "CHIVA 2" (Lung Cancer- IFCT) and "HANOVRE" (Hodgkin's disease - LYSA)
- Study Population for the Physiopathological Substudy "OncoVIRIM":
- Inclusion criteria:
- Participant included in the observatory
- Stable antiretroviral therapy (ART) with controlled HIV-RNA plasma viral load ≤ 50 copies/mL
- Beneficiary of a Social Security program (State Medical Aid or AME is not a Social Security program), article L1121-11 of the Public health code…
- Signed informed consent.
- Non Inclusion Criteria
- Brain or lung radiotherapy \< 30 days
- Transplant organ or bone marrow transplant
- Corticosteroid \> 10 mg per day
- Participant who started ICPi treatment prior to inclusion in the observatory
Exclusion
Key Trial Info
Start Date :
January 17 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 15 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03354936
Start Date
January 17 2018
End Date
June 15 2022
Last Update
January 25 2018
Active Locations (56)
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1
Service d'Immunologie - Hôpital Felix Guyon
La Réunion, Saint-Denis, France, 97405
2
Service d'Hématologie Oncologie - Centre Hospitalier du Pays d'Aix
Aix-en-Provence, France, 13616
3
Service de pneumologie - Hôpital Victor Dupouy
Argenteuil, France, 95100
4
Service d'Onco-Hématologie Immunodépression - Hôpital Henri Duffaut
Avignon, France, 84000