ANRS CO24 OncoVIHAC (Onco VIH Anti Checkpoint)
OncoVIHAC
A Multicenter Observational Cohort for HIV Infected Patients With a Cancer Treated by Immune-Checkpoint Inhibitors.
1 other identifier
observational
50
1 country
56
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-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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2018
Longer than P75 for all trials
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2017
CompletedFirst Posted
Study publicly available on registry
November 28, 2017
CompletedStudy Start
First participant enrolled
January 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2022
CompletedJanuary 25, 2018
January 1, 2018
4 years
September 21, 2017
January 24, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of clinical and biological adverse events occurring with ICPi treatment during the study period
4.5 years
Secondary Outcomes (10)
Immuno-virological evolution
between Month0 and Month24
Immuno-virological evolution
between Month0 and Month 24
Disease status
at Month12 and at Month24
Progression-Free survival
at Month6, Month12, Month18, Month24
For Physiopathological Substudy "OncoVIRIM" : Objective Response Rate (OPR)
At following cures cycles according to the type of treatment : Cycle1 (Week0), Cycle2 (Week2 or Week3), Cycle3 (Week4 or Week6), Cycle9 (Week16) or Cycle9 (Week24), Cycle 15(Week28), Cycle18 (Week52), Cycle27 (Week52), Cycle36 (Week104), Month6, Month12
- +5 more secondary outcomes
Interventions
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
Eligibility Criteria
HIV Infected Patients with a Cancer treated by Immune-Checkpoint Inhibitors.
You may qualify if:
- 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
You may not qualify if:
- \- Subject participating in clinical trials "CHIVA 2" (Lung Cancer- IFCT) and "HANOVRE" (Hodgkin's disease - LYSA)
- Study Population for the Physiopathological Substudy "OncoVIRIM":
- 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.
- Brain or lung radiotherapy \< 30 days
- Transplant organ or bone marrow transplant
- Corticosteroid \> 10 mg per day
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ANRS, Emerging Infectious Diseaseslead
- Pitié-Salpêtrière Hospitalcollaborator
- Bicetre Hospitalcollaborator
Study Sites (56)
Service d'Immunologie - Hôpital Felix Guyon
La Réunion, Saint-Denis, 97405, France
Service d'Hématologie Oncologie - Centre Hospitalier du Pays d'Aix
Aix-en-Provence, 13616, France
Service de pneumologie - Hôpital Victor Dupouy
Argenteuil, 95100, France
Service d'Onco-Hématologie Immunodépression - Hôpital Henri Duffaut
Avignon, 84000, France
Service des Maladies Infectieuses et Tropicales - Hôpital Jean Minjoz
Besançon, 25030, France
Pôle de Médecine 2 - Centre Hospitalier Andrée Rosemon
Cayenne, 97306, France
Service de Médecine interne - Hôpital Antoine Béclère
Clamart, 92141, France
Service d'hématologie - Hôpital Gabriel Montpied
Clermont-Ferrand, 63000, France
Service des Maladies Infectieuses et Tropicales - Hôpital Gabriel Montpied
Clermont-Ferrand, 63000, France
Service d'Immunologie Clinique - Hôpital Henri Mondor
Créteil, 94010, France
Service de Médecine interne - Centre Hospitalier Intercommunal
Créteil, 94010, France
Service de pneumologie - Centre Hospitalier Intercommunal
Créteil, 94010, France
Service Hémopathies Lymphoïdes - Hôpital Henri Mondor
Créteil, 94010, France
Service Oncologie Médicale - Centre Hospitalier Intercommunal
Créteil, 94010, France
Service de Médecine interne et Maladies infectieuses - Hôpital André Mignot
Le Chesnay, 78150, France
Service d'hématologie et oncologie - Hôpital André Mignot
Le Chesnay, 78151, France
Service de Médecine interne-Immunologie clinique - Hôpital Bicêtre
Le Kremlin-Bicêtre, 94276, France
Service des Maladies Infectieuses et Tropicales - Hôpital de la Croix Rousse
Lyon, 69317, France
Ambulatoire-Hôpital de Jour - Institut Paoli Calmettes
Marseille, 13273, France
Service d'hématologie-Cisih - Hôpital Sainte Marguerite
Marseille, 13274, France
Service de dermatologie - Hôpital St Joseph
Marseille, 13285, France
Service de Pneumologie - Hôpital St Joseph
Marseille, 13285, France
Chirurgie Urologique et Tranplantation Rénale - Hôpital de la Conception
Marseille, 13385, France
Service d'Oncologie médicale - Hôpital de la Timone
Marseille, 13385, France
Service dermatologie/vénéréologie - Hôpital de la Timone
Marseille, 13385, France
Service d'oncologie multidiscliplinaire - Hôpital Nord
Marseille, 13915, France
Service de Médecine Interne - Centre Hospitalier de Martigues
Martigues, 13695, France
Service des Maladies Infectieuses et Tropicales - Hôpital Gui de Chauliac
Montpellier, 34295, France
Service de Dermatologie - Hôpital l'Archet
Nice, 06202, France
Service de médecine interne Cancérologie - Hôpital l'Archet
Nice, 06202, France
Service des Maladies Infectieuses et Tropicales - Hôpital l'Archet
Nice, 06202, France
Service des Maladies Infectieuses - Hôpital Saint Antoine
Paris, 75012, France
Service Infectiologie - Hôpital de l'Hôtel-Dieu
Paris, 75101, France
Service d'immuno-pathologie clinique - Hôpital Saint-Louis
Paris, 75475, France
Service des Maladies Infectieuses - Hôpital Saint-Louis
Paris, 75475, France
Servide de Dermatologie - Hôpital Saint-Louis
Paris, 75475, France
Service d'Oncologie Médicale - Hôpital Pitié-Salpêtrière
Paris, 75651, France
Service des Maladies Infectieuses et Tropicales - Hôpital Pitié-Salpêtrière
Paris, 75651, France
Service Hématologie Clinique - Hôpital Pitié-Salpêtrière
Paris, 75651, France
Hôpital Bichat
Paris, 75877, France
Service d'Immunologie Clinique - Hôpital européen Georges Pompidou
Paris, 75908, France
Service de Cancérologie Médicale - Hôpital européen Georges Pompidou
Paris, 75909, France
Service de pneumologie - Hôpital Tenon
Paris, 75970, France
Service des Maladies Infectieuses et Tropicales - Hôpital Tenon
Paris, 75971, France
Service de pneumologie - Hôpital Yves Le Foll
Saint-Brieuc, 22000, France
Service Médecine interne - Maladies Infectieuses - Hôpital Yves Le Foll
Saint-Brieuc, 22000, France
Service Oncologie Hématologie - Hôpital Yves Le Foll
Saint-Brieuc, 22000, France
Centre Hospitalier Universitaire de Saint Etienne
Saint-Priest-en-Jarez, 42270, France
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, 42270, France
Le Trait d'Union - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091, France
Service de Médecine Interne - Hôpital Foch
Suresnes, 92151, France
Service de Pneumologie - Hôpital Foch
Suresnes, 92151, France
Service de Médecine Interne - Hôpital d'Instruction des Armées Saint Anne
Toulon, 83041, France
Service des Maladies Infectieuses et Tropicales - Hôpital Purpan
Toulouse, 31059, France
Service des Maladies Infectieuses et du Voyageur - Centre Hospitalier de Tourcoing
Tourcoing, 59208, France
Département d'Innovation Thérapeutique et d'Essais Précoces - Institut Gustave Roussy
Villejuif, 94800, France
Biospecimen
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.
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Philippe SPANO, MD, PhD
GH Pitié-Salpêtrière-Charles Foix
- PRINCIPAL INVESTIGATOR
Olivier LAMBOTTE, MD, PhD
CHU Bicêtre
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2017
First Posted
November 28, 2017
Study Start
January 17, 2018
Primary Completion
January 1, 2022
Study Completion
June 15, 2022
Last Updated
January 25, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share