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NOT YET RECRUITING

NCT06273943

PHASE3

Impact of Long-acting Injectable Cabotegravir for HIV PrEP in MSM in France.

Sponsor: ANRS, Emerging Infectious Diseases

View on ClinicalTrials.gov

Summary

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.

Official title: 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.

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

322

Start Date

2024-04-01

Completion Date

2026-10-30

Last Updated

2024-02-23

Healthy Volunteers

Conditions

Prevention

Interventions

DRUG

Cabotegravir Tablets, for oral use.

Participants randomly assigned to the cabotegravir arm will be instructed to take by mouth a single tablet of cabotegavir 30mg once daily for four weeks.

DRUG

Cabotegravir Extended-Release Injectable Suspension, for intramuscular use.

Participants will receive 600mg (3mL) CAB LA injections intramuscularly at Month 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 and 24. The injections will be performed in the gluteal muscle by trained healthcare providers at study sites.

DRUG

Tenofovir disoproxil/Emtricitabine 300mg/200mg fixed-dose combination tablets, for oral use

* Daily regimen: a single tablet of TDF/FTC every 24 hours, regardless of sexual activity. If PrEP was stopped, resume with two pills of TDF/FTC followed by one pill every 24 hours. * On-demand regimen: a loading dose of two pills of TDF/FTC 2 to 24 hours before sexual intercourse, a third pill 24 hours after the first drug intake and a fourth pill 24 hours later. In case of daily sexual intercourse, participants will be instructed to take one pill per day until the last sexual intercourse, then to take the two post-exposure pills. If the last dose of TDF/FTC was taken less than one week prior, a leading dose with a single pill of TDF/FTC is sufficient.

PROCEDURE

Rectal Biopsies

This intervention concerns only participants involved in the rectal tissue HIV-1 permissibility sub-study. The proctologist collects ten rectal biopsies at different time points before and after PrEP initiation according to the randomization arm.

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.