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Study of Injectable Cabotegravir Compared to Oral Emtricitabine/Tenofovir for HIV Prevention in Men Who Have Sex with Men

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on HIV prevention in individuals at risk of infection. The research compares two different approaches to pre-exposure prophylaxis (PrEP), which is a preventive treatment that helps protect people from getting HIV. The study evaluates two medications: cabotegravir, which is given as both tablets and long-acting injections, and Truvada, which contains two substances (emtricitabine and tenofovir disoproxil) and is taken as tablets.

The main purpose of the study is to determine how well people maintain their PrEP treatment over time when using either injectable cabotegravir or oral Truvada tablets. The study will last for 24 months, during which participants will receive either cabotegravir (starting with 30 mg tablets followed by 600 mg injections) or Truvada tablets (containing 200 mg emtricitabine and 245 mg tenofovir disoproxil).

Throughout the study, participants will attend regular medical visits where their health will be monitored. These visits will include various health assessments, blood tests, and questionnaires about their experiences with the medication. The study will track how consistently participants use their assigned medication and evaluate its effectiveness in preventing HIV infection.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and medication assignment

    You will be randomly assigned to one of two HIV prevention medication groups

    Group 1 will receive Apretude tablets and injections

    Group 2 will receive Truvada tablets

  2. Step 2

    First month treatment

    If assigned to Group 1: You will take Apretude tablets (30 mg) daily for one month

    If assigned to Group 2: You will continue taking Truvada tablets (200 mg/245 mg) daily or as prescribed

  3. Step 3

    Regular treatment phase

    If in Group 1: You will receive Apretude injections (600 mg) into the muscle every 2 months

    If in Group 2: You will continue taking Truvada tablets as prescribed

  4. Step 4

    Regular check-up visits

    Visits will occur at months 1, 6, 12, 18, and 24

    Each visit includes blood tests, health assessments, and questionnaires about your health and medication use

    Your weight, blood pressure, and blood fat levels will be checked at the start, month 12, and month 24

    Tests for sexually transmitted infections will be conducted regularly

  5. Step 5

    Study completion

    The study continues for 24 months

    Final health assessment and questionnaires will be completed at the last visit

    All test results will be shared with you during the study

Who can join the trial?

5 criteria

  • Must be at least 18 years old
  • Must be a cisgender man who has sex with men (cisgender means your gender identity matches the sex assigned at birth)
  • Must have been taking oral PrEP medication (TDF/FTC - medications that help prevent HIV infection) for at least 6 months, either daily or on-demand, with proof of prescription
  • Must be affiliated with or be a beneficiary of a social security scheme
  • Must be able to provide informed written consent by signing the study documents before any study procedures begin

Who cannot join the trial?

13 criteria

  • Current HIV infection (having the human immunodeficiency virus)
  • Previous use of PrEP medications (HIV prevention drugs) in the last 12 months
  • Age below 18 or above 65 years
  • Female participants (study is limited to male subjects only)
  • Known allergies to study medications (cabotegravir or TDF/FTC)
  • Serious kidney problems, as they may affect the medication processing
  • Active hepatitis B infection (liver inflammation caused by hepatitis B virus)
  • Significant liver function abnormalities
  • Current participation in other clinical trials
  • History of blood clotting disorders
  • Unstable or serious medical conditions that could interfere with study procedures
  • Unable to follow study procedures or attend regular visits
  • History of substance abuse that could impact adherence to study protocol
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Investigated drugs

  • Cabotegravir

    is a long-acting injectable medication used for HIV prevention (PrEP - Pre-Exposure Prophylaxis). It is administered through injections and remains active in the body for an extended period, helping to prevent HIV infection in people who are at risk.

  • Tenofovir/Emtricitabine (TDF/FTC)

    is an oral medication taken daily for HIV prevention (PrEP). This combination pill helps prevent HIV infection by blocking the virus from establishing itself in the body. It is commonly known by the brand name Truvada and has been widely used as a standard PrEP medication.

What is already known about the treatment

  • Cabotegravir

    A long-acting injectable medication used for HIV pre-exposure prophylaxis (PrEP) that provides an alternative to daily oral pills. This integrase strand transfer inhibitor works by blocking the HIV virus from inserting its genetic material into human cells, thereby preventing infection. The medication is administered through intramuscular injections at specified intervals, offering extended protection against HIV infection, particularly beneficial for individuals who may have difficulty adhering to daily oral medication schedules.

  • Tenofovir/Emtricitabine (TDF/FTC)

    An oral combination medication taken daily for HIV pre-exposure prophylaxis (PrEP), commonly known under various brand names. This medication combines two antiretroviral drugs that work together to prevent HIV from replicating in the body, effectively reducing the risk of HIV infection when taken consistently. The tablet form requires daily administration and has been a standard option for PrEP, proven effective in multiple clinical trials for preventing HIV transmission in high-risk populations.

Investigated diseases

HIV (Human Immunodeficiency Virus) - A viral infection that attacks the body's immune system, specifically targeting CD4 cells (T cells) which help the immune system fight off infections. The virus can be transmitted through bodily fluids, including blood, semen, vaginal fluids, and breast milk. Without intervention, the virus gradually weakens the immune system over time. The infection progresses through several stages, from acute infection with flu-like symptoms to a clinical latency stage where the virus is still active but reproduces at very low levels. People with HIV can live long, healthy lives with proper medical care.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-510678-25-00Protocol codeANRS 0410sEstimated enrolment322 patientsSponsorInserm

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).