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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

322 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2026-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily Regimen or a Long-acting Injectable Regimen Every Two Months for Treatment of Human Immunodeficiency Virus (HIV-1) in Adults Who Have Not Previously Taken Antiretroviral Therapy

NCT05917509

HIV Infections

ACTIVE_NOT_RECRUITING PHASE3

Study of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living With HIV-1, Two to Less Than 12 Years of Age

NCT05660980

HIV-1-infection

RECRUITING PHASE1/PHASE2

Acceptability and Feasibility of Injectable Cabotegravir Pre-exposure Prophylaxis (PrEP) Versus Oral PrEP in Routine Care up to 15 Months in Private Pharmacies in South Africa

NCT06138600

HIV Infections

ACTIVE_NOT_RECRUITING PHASE3

A Study Evaluating Implementation Strategies for Cabotegravir (CAB)+ Rilpivirine (RPV) Long-acting (LA) Injectables for Human Immunodeficiency Virus (HIV)-1 Treatment in European Countries

NCT04399551

HIV Infections

COMPLETED PHASE3

PrEPared to Choose (PtC) is an Implementation Study of the Delivery of Cabotegravir Long-acting, an Injectable Pre-exposure Prophylaxis (PrEP) Option for HIV Prevention. Injectable PrEP Will be Offered Alongside Oral and Vaginal Ring PrEP From Within a Real-world Context in Cape Town, South Africa.

NCT06807736

HIV Infection Sexual and Reproductive Health

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Long-acting injectable cabotegravir (CAB-LA) is a promising agent to address the issue of uptake, adherence, and persistence among oral PrEP users who faced adherence challenges. However, the potential benefits of offering CAB-LA as an additional prevention option for MSM adherent to oral PrEP has yet to be demonstrated. We hypothesize that offering CAB-LA as an additional prevention option for MSM already using oral PrEP can mitigate PrEP fatigue over time, resulting in enhanced PrEP use and increased coverage of at-risk sexual intercourses.

This study is designed as a pragmatic, open-label, multicenter, parallel-group, randomized controlled clinical trial aiming to enroll MSM using PrEP for at least 6 months. 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). Participants will be enrolled over 6 months and followed for two years. The trial will be conducted at 9 clinical sites in the Paris region. The primary objective of the study will be to compare the sustained PrEP use over time among participants randomized to CAB-LA vs. oral TDF/FTC based PrEP at Months 12 and 24. The main secondary objectives will aim to evaluate the PrEP coverage of at-risk sexual intercourses, the change from baseline in sexual risk behaviors, the safety of the drugs, and the HIV incidence.

The study protocol includes three ancillary studies:

* Social science: Focus groups will be conducted among study participants to investigate their perceptions of CAB-LA, motivations for using it, adherence and persistence, changes in HIV risk perception, and impact on sexual satisfaction. Additionally, this study will assess healthcare providers' perceptions, barriers, and facilitators regarding CAB-LA implementation for PrEP.
* Rectal tissue HIV-1 permissibility: This study aims to evaluate the protection from HIV-1 at different time points after oral and injectable CAB initiation using a model of Ex-vivo rectal tissue and PBMCs infection with HIV-1.
* Medico-economics analysis: The main objective of this study is to establish cost-effectiveness performance benchmarks for CAB-LA in HIV PrEP.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prevention

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Oral PrEP with daily or on-demand TDF/FTC

Participants randomly assigned to the oral PrEP regimen will be instructed to take a single dose combination of TDF 300 mg + FTC 200 mg (TDF/FTC), either daily or on-demand, according to their preferences.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

* 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.

Rectal Biopsies

Intervention Type PROCEDURE

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.

Long-acting injectable PrEP with cabotegavir

Participants assigned to the cabotegravir group will initially take a 30mg oral tablet of cabotegravir daily for a four-week period. Following this initial phase, they will receive 13 intramuscular injections of 600mg (3mL) long-acting injectable cabotegravir (CAB-LA) administered every two months after an initial loading dose given one month after the last oral tablet.

Group Type EXPERIMENTAL

Cabotegravir Tablets, for oral use.

Intervention Type DRUG

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.

Cabotegravir Extended-Release Injectable Suspension, for intramuscular use.

Intervention Type DRUG

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.

Rectal Biopsies

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

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.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

VOCABRIA APRETUDE TRUVADA

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jean-Michel Molina, Professor

Role: PRINCIPAL_INVESTIGATOR

Saint-Louis Hospital, Paris, France

Locations

Explore where the study is taking place and check the recruitment status at each participating site.