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.

ANRS 0410s CABOPrEP

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.

2024-04-01

2025-10-30

2026-10-30

Not yet recruiting

Early phase I

322

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned in a 1:1 ratio to remain on their current oral PrEP regimen with daily and/or on-demand TDF/FTC (Control arm) or to switch to a CAB-LA based PrEP (Intervention arm).', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 322, 'type': 'ESTIMATED'}}

2024-02-23