Clinical trial · Observational
ANRS CO24 OncoVIHAC (Onco VIH Anti Checkpoint)
A Multicenter Observational Cohort for HIV Infected Patients With a Cancer Treated by Immune-Checkpoint Inhibitors.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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-PD-1 or anti-PDL-1 or anti-CTLA4, monitored in some French hospitals . The objective of the study is to assess the safety of these new agents in HIV-infected patients. As an observatory, the number of participants planned is not predetermined: the aim is to include for 2 years any participant infected with HIV and having a cancer treated by ICPi in one of the centers that have agreed to participate. 50 participants will be recruited for Substudy "OncoVIRIM" during the study period (regardless of tumor type or ICPi type); 8 or 9 time points (blood samples) will be scheduled The cohort " ANRS CO24 OncoVIHAC " is declared to authorities like category 2 research . No intervention in the observatory, a collection of data will be carried out in M0, M6, M12, M18 and M24. For the physiopathological Substudy OncoVIRIM : Blood samples will be collected to constitute cell bank, plasma bank, serum bank, DNA bank in order to meet the objectives of this substudy and possibly for complementary research
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HIV Infected Patients With Cancer Treated by ICPi | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sample | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Incidence of clinical and biological adverse events occurring with ICPi treatment during the study period
- timeFrame
- 4.5 years
Secondary outcomes (10)
- measure
- Immuno-virological evolution
- timeFrame
- between Month0 and Month24
- description
- HIV-RNA plasma viral load copies/mL
- measure
- Immuno-virological evolution
- timeFrame
- between Month0 and Month 24
- description
- CD4+ and CD8+ T cells counts /mm3 and %, CD4/CD8 ratio.
- measure
- Disease status
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available