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ANRS CO24 OncoVIHAC (Onco VIH Anti Checkpoint)

NCT03354936 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2018-01-25

No results posted yet for this study

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-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

  • HIV Infected Patients With Cancer Treated by ICPi

Interventions

BIOLOGICAL

Blood sample

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

Sponsors & Collaborators

  • Pitié-Salpêtrière Hospital

    collaborator OTHER

  • Bicetre Hospital

    collaborator OTHER

  • ANRS, Emerging Infectious Diseases

    lead OTHER_GOV

Principal Investigators

  • Jean-Philippe SPANO, MD, PhD · GH Pitié-Salpêtrière-Charles Foix

  • Olivier LAMBOTTE, MD, PhD · CHU Bicêtre

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-17
Primary Completion
2022-01-01
Completion
2022-06-15

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03354936 on ClinicalTrials.gov