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

NCT06273943 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 322

Last updated 2024-02-23

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • ANRS, Emerging Infectious Diseases

    lead OTHER_GOV

Principal Investigators

  • Jean-Michel Molina, Professor · Saint-Louis Hospital, Paris, France

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2025-10-30
Completion
2026-10-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06273943 on ClinicalTrials.gov