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 study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Hopital Beaujon Clichy France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
01.09.2024

Trial locations

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.

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 ID:
2024-510678-25-00
Protocol code:
ANRS 0410s
NCT ID:
NCT06273943
Trial Phase:
Human Pharmacology (Phase I) – Other

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