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.

Prior treatment

• Treatment with oral anticoagulant (antiplatelet agents are allowed).
• Surgically placed buttock implants.
• Concomitant use of antimycobacterial (rifampin, rifapentine) or enzyme-inducing anticonvulsants (carbamazepine, oxcarbazepine, phenobarbital, phenytoin, etc.).

Other illness

• Positive HIV test result at screening or enrollment visit, even if HIV infection is not confirmed.
• 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.
• Known or suspected allergy to study product components.
• 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.
• 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.
• 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.

Lab values

• Creatinine clearance lower than 50 mL/min.

Other

• Aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) > 5-fold the upper normal limit (UNL).
• Planned trip abroad of more than 2 consecutive months or planned move outside the Ile de France region.
• Person participating in another research study with an exclusion period still in progress at inclusion.
• 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.
• 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).