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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.
EU CTIS ID: 2024-510678-25-00
What this study is testing
To compare the sustained PrEP use over time among participants randomized to cabotegravir vs. oral TDF/FTC based PrEP at Month 12.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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).
You likely can't join if
- - Positive HIV test result at screening or enrollment visit, even if HIV infection is not confirmed.
- - Aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) > 5-fold the upper normal limit (UNL).
- - Creatinine clearance lower than 50 mL/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.
See the full eligibility 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.
- 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).
- - Positive HIV test result at screening or enrollment visit, even if HIV infection is not confirmed.
- - Aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) > 5-fold the upper normal limit (UNL).
- - Creatinine clearance lower than 50 mL/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.
- - Symptoms and/or clinical signs consistent with an acute HIV infection.
- - 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.
- - 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.