Study of MK-8527 taken once monthly compared to emtricitabine/tenofovir taken daily for HIV-1 prevention

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What is this study about?

This clinical trial focuses on preventing HIV-1 infection using two different medications. The study compares a new experimental drug called MK-8527 taken once monthly with a combination of emtricitabine and tenofovir taken daily. The purpose is to determine if the new monthly medication is as effective and safe as the daily treatment in preventing HIV-1 infection.

The study uses film-coated tablets that contain either the active medications or placebo. Participants will receive either MK-8527 once per month or the combination of emtricitabine and tenofovir once per day. The study will monitor how well these medications prevent HIV-1 infection and evaluate their safety over time.

During the study, participants will take their assigned medication as directed and attend regular medical visits. The medications are taken by mouth, and the study team will track any health changes that occur. The study will look at how many people develop HIV-1 infection while taking the medications and monitor any side effects that may occur.

1 Initial medication assignment

You will be randomly assigned to receive either MK-8527 taken once monthly or emtricitabine/tenofovir taken daily

Both medications are taken orally in the form of film-coated tablets

The purpose is to prevent HIV-1 infection

2 Treatment period

If assigned to MK-8527: Take one tablet once per month

If assigned to emtricitabine/tenofovir: Take one tablet daily

The treatment period will continue from September 2025 through October 2027

3 Regular health monitoring

Regular HIV-1/HIV-2 testing will be conducted to confirm negative status

Your health status will be monitored for any side effects

Medical staff will track and document any health-related events that occur during the study

4 Safety assessment

Any side effects will be documented and evaluated

If side effects occur, the medical team will assess whether it is safe to continue the medication

You may need to stop taking the study medication if significant side effects occur

5 Study completion

The study will conclude in October 2027

Final HIV testing and health evaluations will be conducted

Your participation will end after the final assessment

Who Can Join the Study?

Must test negative for HIV-1 and HIV-2 during screening
Must be one of the following:
- A cisgender man (person whose gender identity matches their birth sex)
- A transgender woman (person assigned male at birth who identifies as female)
- A transgender man (person assigned female at birth who identifies as male)
- A gender nonbinary person (person who does not identify exclusively as male or female)
Must have had at least one of these experiences:
- Unprotected receptive anal sex in the past 12 months (not including sex with a committed monogamous partner)
- Receptive anal sex with 2 or more partners in the past 3 months (with or without protection)
- Had gonorrhea or chlamydia (infections) in the rectum or urethra, or new syphilis infection in the past 6 months
- Used stimulant drugs during sexual activity in the past 3 months
Must be at least 16 years old
Must weigh at least 35 kilograms (approximately 77 pounds)

Who Cannot Join the Study?

Positive test result for HIV-1 (Human Immunodeficiency Virus type 1)
Known allergy or sensitivity to any components of the study medications
Active or chronic hepatitis B infection (liver inflammation caused by hepatitis B virus)
Significant kidney problems or decreased kidney function
Current pregnancy or breastfeeding
History of bone disorders or significant bone loss
Active, untreated sexually transmitted infections
Use of certain medications that could interact with study drugs
History of serious medical conditions that could interfere with study participation
Participation in another clinical trial within the past 30 days
History of poor compliance with medical treatments
Active substance abuse or dependence
Mental health conditions that could affect ability to follow study procedures
Abnormal laboratory test results that indicate health issues
High risk of complications based on medical history

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Hopital Beaujon	Clichy	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	08.09.2025

Trial locations

Investigated drugs:

Emtricitabine

MK-8527 is an experimental medication taken once a month by mouth to help prevent HIV-1 infection in people who are at risk of getting HIV. This is known as pre-exposure prophylaxis (PrEP).

FTC/TDF (emtricitabine/tenofovir disoproxil fumarate) is a daily oral medication currently used to prevent HIV infection. It’s a combination of two medications that work together to reduce the risk of getting HIV-1 when taken regularly.

HIV (Human Immunodeficiency Virus) Infection – A viral infection that affects the immune system by targeting CD4 cells, which help the body fight infections. The virus can spread through direct contact with certain body fluids from a person infected with HIV. Initially, a person may experience flu-like symptoms during the acute phase, followed by a period with no obvious symptoms. Without intervention, the virus continues to multiply and gradually weakens the immune system over time. The virus specifically attacks T cells (also called CD4 cells), which are crucial for maintaining the body’s defense system.

Trial ID:

2025-520610-58-00

Protocol code:

MK-8527-011

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of MK-8527 taken once monthly compared to emtricitabine/tenofovir taken daily for HIV-1 prevention

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?