NCT03354936: OncoVIHAC

ANRS CO24 OncoVIHAC (Onco VIH Anti Checkpoint)

Status unknown Last updated 25 January 2018

What this trial tests

trial testing Blood sample in HIV Infected Patients With Cancer Treated by ICPi in 50 participants. Status unknown.

Timeline

17 January 2018

Primary endpoint
1 January 2022

15 June 2022

Quick facts

Lead sponsor	ANRS, Emerging Infectious Diseases
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	50
Start date	17 January 2018
Primary completion	1 January 2022
Estimated completion	15 June 2022
Sites	56 locations across France

Drugs / interventions tested

• Blood sample — full drug profile →

Conditions studied

• HIV Infected Patients With Cancer Treated by ICPi — all drugs for HIV Infected Patients With Cancer Treated by ICPi →

Sponsor

ANRS, Emerging Infectious Diseases — full company profile →

Who can join

18 and older, any sex, with HIV Infected Patients With Cancer Treated by ICPi. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Barriers and strategies to achieve a cure for HIV.
   Pitman MC, Lau JSY, McMahon JH, Lewin SR. · · 2018 · cited 99× · PMID 29893245 · DOI 10.1016/s2352-3018(18)30039-0
2. Immune Checkpoints in Viral Infections.
   Cai H, Liu G, Zhong J, Zheng K, et al · · 2020 · cited 46× · PMID 32967229 · DOI 10.3390/v12091051
3. Immunotherapy use outside clinical trial populations: never say never?
   Rzeniewicz K, Larkin J, Menzies AM, Turajlic S. · · 2021 · cited 28× · PMID 33771665 · DOI 10.1016/j.annonc.2021.03.199
4. Immune Checkpoint Inhibitors in People Living with HIV/AIDS: Facts and Controversies.
   Castelli V, Lombardi A, Palomba E, Bozzi G, et al · · 2021 · cited 27× · PMID 34571876 · DOI 10.3390/cells10092227
5. Immune checkpoint inhibitors as potential therapy for reverting T-cell exhaustion and reverting HIV latency in people living with HIV.
   Benito JM, Restrepo C, García-Foncillas J, Rallón N. · · 2023 · cited 20× · PMID 38130714 · DOI 10.3389/fimmu.2023.1270881
6. Soluble Immune Checkpoints Are Dysregulated in COVID-19 and Heavy Alcohol Users With HIV Infection.
   Li W, Syed F, Yu R, Yang J, et al · · 2022 · cited 16× · PMID 35281051 · DOI 10.3389/fimmu.2022.833310
7. Crossroads of Cancer and HIV-1: Pathways to a Cure for HIV.
   Gavegnano C, Savarino A, Owanikoko T, Marconi VC. · · 2019 · cited 13× · PMID 31636630 · DOI 10.3389/fimmu.2019.02267
8. Safety and tolerability of immune checkpoint inhibitors in people with HIV infection and cancer: insights from the national prospective real-world OncoVIHAC ANRS CO24 cohort study.
   Assoumou L, Baldé R, Katlama C, Abbar B, et al · · 2024 · cited 12× · PMID 39179255 · DOI 10.1136/jitc-2024-009728