Informations générales (source: ClinicalTrials.gov)
Impact of Long-acting Injectable Cabotegravir for HIV Pre-exposure Prophylaxis Persistence and Coverage in Men Who Have Sex With Men in France: a Randomized Controlled Clinical Trial.
Interventional
Phase 3
ANRS, Emerging Infectious Diseases (Voir sur ClinicalTrials)
avril 2024
octobre 2026
16 septembre 2025
The purpose of this study is to evaluate if offering long-acting injectable cabotegravir
(CAB-LA) as an additional HIV prevention choice among oral PrEP-experienced men who have
sex with men (MSM) in France can significantly increase the sustained PrEP use over time
and the PrEP coverage of at-risk sexual risk behaviors.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Bichat | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Necker-Enfants Malades | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Saint Antoine | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Tenon | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Hôpital Hôtel Dieu - 75004 - Paris - Ile De France - France | Contact (sur clinicalTrials) | ||||
| Hôpital La Pitié Salpêtrière - 75013 - Paris - Ile De France - France | Contact (sur clinicalTrials) | ||||
| Hôpital Lariboisière - 75010 - Paris - Ile De France - France | Contact (sur clinicalTrials) | ||||
| Hôpital Saint Louis - 75010 - Paris - Ile De France - France | Contact (sur clinicalTrials) | ||||
Critères
Homme
Inclusion criteria
- Age ≥ 18 years.
- Cisgender men who have sex with men.
- Have taken oral TDF/FTC based PrEP during the past 6 months, either daily or
on-demand, with a documented PrEP prescription.
- Agreeing to be contacted personally by telephone (call, SMS) or e-mail.
- Person affiliated with or a beneficiary of a social security scheme (article
L1121-11 of the Public Health Code).
- Informed and written consent, signed by the person and the investigator on the day
of inclusion, at the latest, and before any examination carried out within the
setting of the study (article L1122-1-1 of the Public Health Code).
Non-inclusion criteria
- Positive HIV test result at screening or enrollment visit, even if HIV infection is
not confirmed.
- Symptoms and/or clinical signs consistent with an acute HIV infection.
- History of seizure disorder.
- Ongoing Post-Exposure Prophylaxis (PEP) for HIV.
- Last titer of hepatitis B surface antibody (anti-HBs) < 10 mIU/mL.
- Concomitant use of antimycobacterial (rifampin, rifapentine) or enzyme-inducing
anticonvulsants (carbamazepine, oxcarbazepine, phenobarbital, phenytoin, etc.).
- Participants with severe hepatic impairment (Class C) as determined by Child-Pugh
classification.
- Participants having a non-treated chronic HCV infection.
- Current or chronic history of liver disease or known hepatic or biliary
abnormalities.
- Aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) > 5-fold the
upper normal limit (UNL).
- Creatinine clearance lower than 50mL/min.
- History of chronic renal disease, osteoporosis or osteopenia.
- Inflammatory skin conditions which compromise the safety of intramuscular (IM)
injections.
- Known thrombocytopenia or any other known bleeding disorder, which would
contraindicate IM injection.
- Treatment with oral anticoagulant (antiplatelet agents are allowed).
- Known or suspected allergy to study product components.
- Surgically placed buttock implants.
- Planned trip abroad of more than 2 consecutive months or planned move outside the
Ile de France region.
- Individuals who, upon the investigator's judgement, will not be likely to comply the
clinical trial procedures, or with any condition incompatible with study
participation.
- Person participating in another research study with an exclusion period still in
progress at inclusion. Participants in the ANRS PREVENIR study are authorized to
participate in the ANRS CABOPrEP trial.
- Person under guardianship or curatorship or deprived of liberty by judicial or
administrative decision.
- Age ≥ 18 years.
- Cisgender men who have sex with men.
- Have taken oral TDF/FTC based PrEP during the past 6 months, either daily or
on-demand, with a documented PrEP prescription.
- Agreeing to be contacted personally by telephone (call, SMS) or e-mail.
- Person affiliated with or a beneficiary of a social security scheme (article
L1121-11 of the Public Health Code).
- Informed and written consent, signed by the person and the investigator on the day
of inclusion, at the latest, and before any examination carried out within the
setting of the study (article L1122-1-1 of the Public Health Code).
Non-inclusion criteria
- Positive HIV test result at screening or enrollment visit, even if HIV infection is
not confirmed.
- Symptoms and/or clinical signs consistent with an acute HIV infection.
- History of seizure disorder.
- Ongoing Post-Exposure Prophylaxis (PEP) for HIV.
- Last titer of hepatitis B surface antibody (anti-HBs) < 10 mIU/mL.
- Concomitant use of antimycobacterial (rifampin, rifapentine) or enzyme-inducing
anticonvulsants (carbamazepine, oxcarbazepine, phenobarbital, phenytoin, etc.).
- Participants with severe hepatic impairment (Class C) as determined by Child-Pugh
classification.
- Participants having a non-treated chronic HCV infection.
- Current or chronic history of liver disease or known hepatic or biliary
abnormalities.
- Aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) > 5-fold the
upper normal limit (UNL).
- Creatinine clearance lower than 50mL/min.
- History of chronic renal disease, osteoporosis or osteopenia.
- Inflammatory skin conditions which compromise the safety of intramuscular (IM)
injections.
- Known thrombocytopenia or any other known bleeding disorder, which would
contraindicate IM injection.
- Treatment with oral anticoagulant (antiplatelet agents are allowed).
- Known or suspected allergy to study product components.
- Surgically placed buttock implants.
- Planned trip abroad of more than 2 consecutive months or planned move outside the
Ile de France region.
- Individuals who, upon the investigator's judgement, will not be likely to comply the
clinical trial procedures, or with any condition incompatible with study
participation.
- Person participating in another research study with an exclusion period still in
progress at inclusion. Participants in the ANRS PREVENIR study are authorized to
participate in the ANRS CABOPrEP trial.
- Person under guardianship or curatorship or deprived of liberty by judicial or
administrative decision.