Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2018-01-17
2022-06-15
Brief Summary
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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
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Detailed Description
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Secondary objectives
* To evaluate evolution of HIV immunological and virological data in HIV infected patients with cancer treated by Immune-Checkpoint Inhibitors (ICPi):
* HIV-RNA plasma viral load
* Evolution of CD4+ and CD8+ T cells counts, CD4/CD8 ratio
* To assess the efficacy endpoint : progression-free survival, overall survival rate at 1 year and 2 years.
* Potential Modification of antiretroviral therapy
Secondary objectives of the Physiopathological Substudy "OncoVIRIM" (Limited to a few clinical centers with a suitable technical tray) :
* To evaluate response to ICPi treatment according to RECIST criteria (solid tumor) and CHESON criteria (lymphoma)
* Other immunological and virological explorations on HIV :
* To evaluate low level HIV replication and size of the HIV reservoir
* To evaluate effects of ICPi on HIV-specific immune responses
* To show the effects of ICPi on HIV-related immune alterations such as T cell differentiation, T cell activation/exhaustion and systemic inflammation
* To demonstrate an effect on other viruses-specific T cells and viremia (EBV, CMV, HHV-8, HBV et HCV (if co-infected)
* To better understand the pathophysiology of ICPi-related immune adverse effects, particularly the development of infraclinical auto-immunity : monitoring of autoantibodies and analysis of changes in B cell antibodies repertoires
* To find immune biomarkers predictive for clinical response to ICPi, MHC class I and II in particular and description of any gene of interest in the context of ICPi treatment
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* Participant who started ICPi treatment prior to inclusion in the observatory
Exclusion Criteria
Study Population for the Physiopathological Substudy "OncoVIRIM":
18 Years
ALL
No
Sponsors
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Pitié-Salpêtrière Hospital
OTHER
Bicetre Hospital
OTHER
ANRS, Emerging Infectious Diseases
OTHER_GOV
Responsible Party
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Principal Investigators
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Jean-Philippe SPANO, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
GH Pitié-Salpêtrière-Charles Foix
Olivier LAMBOTTE, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
CHU Bicêtre
Locations
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Service d'Immunologie - Hôpital Felix Guyon
La Réunion, Saint-Denis, France
Service d'Hématologie Oncologie - Centre Hospitalier du Pays d'Aix
Aix-en-Provence, , France
Service de pneumologie - Hôpital Victor Dupouy
Argenteuil, , France
Service d'Onco-Hématologie Immunodépression - Hôpital Henri Duffaut
Avignon, , France
Service des Maladies Infectieuses et Tropicales - Hôpital Jean Minjoz
Besançon, , France
Pôle de Médecine 2 - Centre Hospitalier Andrée Rosemon
Cayenne, , France
Service de Médecine interne - Hôpital Antoine Béclère
Clamart, , France
Service d'hématologie - Hôpital Gabriel Montpied
Clermont-Ferrand, , France
Service des Maladies Infectieuses et Tropicales - Hôpital Gabriel Montpied
Clermont-Ferrand, , France
Service d'Immunologie Clinique - Hôpital Henri Mondor
Créteil, , France
Service de Médecine interne - Centre Hospitalier Intercommunal
Créteil, , France
Service de pneumologie - Centre Hospitalier Intercommunal
Créteil, , France
Service Hémopathies Lymphoïdes - Hôpital Henri Mondor
Créteil, , France
Service Oncologie Médicale - Centre Hospitalier Intercommunal
Créteil, , France
Service de Médecine interne et Maladies infectieuses - Hôpital André Mignot
Le Chesnay, , France
Service d'hématologie et oncologie - Hôpital André Mignot
Le Chesnay, , France
Service de Médecine interne-Immunologie clinique - Hôpital Bicêtre
Le Kremlin-Bicêtre, , France
Service des Maladies Infectieuses et Tropicales - Hôpital de la Croix Rousse
Lyon, , France
Ambulatoire-Hôpital de Jour - Institut Paoli Calmettes
Marseille, , France
Service d'hématologie-Cisih - Hôpital Sainte Marguerite
Marseille, , France
Service de dermatologie - Hôpital St Joseph
Marseille, , France
Service de Pneumologie - Hôpital St Joseph
Marseille, , France
Chirurgie Urologique et Tranplantation Rénale - Hôpital de la Conception
Marseille, , France
Service d'Oncologie médicale - Hôpital de la Timone
Marseille, , France
Service dermatologie/vénéréologie - Hôpital de la Timone
Marseille, , France
Service d'oncologie multidiscliplinaire - Hôpital Nord
Marseille, , France
Service de Médecine Interne - Centre Hospitalier de Martigues
Martigues, , France
Service des Maladies Infectieuses et Tropicales - Hôpital Gui de Chauliac
Montpellier, , France
Service de Dermatologie - Hôpital l'Archet
Nice, , France
Service de médecine interne Cancérologie - Hôpital l'Archet
Nice, , France
Service des Maladies Infectieuses et Tropicales - Hôpital l'Archet
Nice, , France
Service des Maladies Infectieuses - Hôpital Saint Antoine
Paris, , France
Service Infectiologie - Hôpital de l'Hôtel-Dieu
Paris, , France
Service d'immuno-pathologie clinique - Hôpital Saint-Louis
Paris, , France
Service des Maladies Infectieuses - Hôpital Saint-Louis
Paris, , France
Servide de Dermatologie - Hôpital Saint-Louis
Paris, , France
Service d'Oncologie Médicale - Hôpital Pitié-Salpêtrière
Paris, , France
Service des Maladies Infectieuses et Tropicales - Hôpital Pitié-Salpêtrière
Paris, , France
Service Hématologie Clinique - Hôpital Pitié-Salpêtrière
Paris, , France
Hôpital Bichat
Paris, , France
Service d'Immunologie Clinique - Hôpital européen Georges Pompidou
Paris, , France
Service de Cancérologie Médicale - Hôpital européen Georges Pompidou
Paris, , France
Service de pneumologie - Hôpital Tenon
Paris, , France
Service des Maladies Infectieuses et Tropicales - Hôpital Tenon
Paris, , France
Service de pneumologie - Hôpital Yves Le Foll
Saint-Brieuc, , France
Service Médecine interne - Maladies Infectieuses - Hôpital Yves Le Foll
Saint-Brieuc, , France
Service Oncologie Hématologie - Hôpital Yves Le Foll
Saint-Brieuc, , France
Centre Hospitalier Universitaire de Saint Etienne
Saint-Priest-en-Jarez, , France
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, , France
Le Trait d'Union - Hôpitaux Universitaires de Strasbourg
Strasbourg, , France
Service de Médecine Interne - Hôpital Foch
Suresnes, , France
Service de Pneumologie - Hôpital Foch
Suresnes, , France
Service de Médecine Interne - Hôpital d'Instruction des Armées Saint Anne
Toulon, , France
Service des Maladies Infectieuses et Tropicales - Hôpital Purpan
Toulouse, , France
Service des Maladies Infectieuses et du Voyageur - Centre Hospitalier de Tourcoing
Tourcoing, , France
Département d'Innovation Thérapeutique et d'Essais Précoces - Institut Gustave Roussy
Villejuif, , France
Countries
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Central Contacts
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Facility Contacts
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Catherine GAUD, MD
Role: primary
Thierry ALLEGRE, MD
Role: primary
Laure BELMONT, MD
Role: primary
Gilles PICHANCOURT, MD
Role: primary
Catherine CHIROUZE, MD
Role: primary
Jean-François BOUE, MD
Role: primary
Cécile MOLUCON-CHABROT, MD
Role: primary
Christine JACOMET, MD
Role: primary
Jean-Daniel LELIEVRE, MD
Role: primary
Valérie GARRAIT, MD
Role: primary
Isabelle MONNET, MD
Role: primary
Corinne HAIOUN, MD
Role: primary
Isabelle COJEAN-ZELEK
Role: primary
Alix GREDER-BELAN, MD
Role: primary
Caroline BESSON, MD
Role: primary
Olivier LAMBOTTE, MD
Role: primary
Laurent COTTE, MD
Role: primary
Jean-François MOULIN, MD
Role: primary
Isabelle POIZOT-MARTIN, MD
Role: primary
Frank TOLLINCHI, MD
Role: primary
Christina AUDOLY, MD
Role: primary
Eric LECHEVALLIER, MD
Role: primary
Jean-Laurent DEVILLE, MD
Role: primary
Jean-Jacques GROB, MD
Role: primary
Laurent GREILLIER, MD
Role: primary
Rolande COHEN VALENSI, MD
Role: primary
Alain MAKINSON, MD
Role: primary
Alexandra PICARD, MD
Role: primary
Eric ROSENTHAL, MD
Role: primary
Alissa NAQVI, MD
Role: primary
Karine LACOMBE, MD
Role: primary
Dominique SALMON-CERON, MD
Role: primary
Laurence GERARD, MD
Role: primary
Diane PONSCARME, MD
Role: primary
Céleste LEBBE, MD
Role: primary
Jean-Philippe SPANO, MD
Role: primary
Christine KATLAMA, MD
Role: primary
Sylvain CHOQUET
Role: primary
Yazdan YAZDANPANAH, MD
Role: primary
Laurence WEISS, MD
Role: primary
Stéphane OUDARD, MD
Role: primary
Armelle LAVOLE, MD
Role: primary
Gilles PIALOUX, MD
Role: primary
Gwenaëlle LE GARFF, MD
Role: primary
Corinne DANIEL, MD
Role: primary
Corinne ALLEAUME, MD
Role: primary
Anne FRESARD, MD
Role: primary
Pierre FOURNEL, MD
Role: primary
Marie-Laure BATARD, MD
Role: primary
David ZUCMAN, MD
Role: primary
Jean-Louis COUDERC, MD
Role: primary
Jean-Pierre DE JAUREGUIBERRY, MD
Role: primary
Pierre DELOBEL, MD
Role: primary
Faïza AJANA, MD
Role: primary
Aurélien MARABELLE, MD
Role: primary
Other Identifiers
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2017-A00699-44
Identifier Type: -
Identifier Source: org_study_id
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