RecruitingPHASE3INTERVENTIONAL

A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)

This clinical study is looking for a new way to prevent HIV (Human Immunodeficiency Virus) infection. Researchers are testing a new medicine called MK-8527, which is taken as a tablet once a month. The main aim is to find out if this monthly tablet works just as well, or even better, than the current daily pre-exposure prophylaxis (PrEP) medicines used to prevent HIV. They also want to understand if MK-8527 is safe to use and whether people find it easy to take without too many side effects. If successful, this could offer a new, more convenient option for people who want to protect themselves from HIV, potentially making it easier for more people to stick to their prevention plan.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

4,390

Start

31 Jul 2025

Estimated completion

22 Jul 2027

Human Immunodeficiency Virus (HIV)HIV Pre-Exposure Prophylaxis

What is this study about?

This study is a research project aiming to find new and more convenient ways to prevent HIV. HIV is a virus that can weaken the immune system, making it harder for the body to fight off infections and diseases. Currently, there are effective daily medicines, known as PrEP (pre-exposure prophylaxis), that can greatly reduce the risk of getting HIV if taken consistently.

However, taking a daily tablet can sometimes be challenging for people to remember. This new study is exploring if a medicine called MK-8527, taken as a tablet just once a month, could offer the same strong protection against HIV as the daily medicines. Researchers are also very keen to ensure that this new medicine is safe for people to use and that any side effects are manageable.

Finding a monthly prevention option could make it much easier for people to protect themselves from HIV, potentially leading to more people being able to use this vital prevention method. This study is an important step towards expanding the choices available for HIV prevention.

Key takeaways

A new monthly tablet (MK-8527) is being tested to prevent HIV.
The study compares MK-8527 to a daily HIV prevention medicine (PrEP).
Researchers want to know if MK-8527 is safe and works well.
This could offer a more convenient way to protect against HIV.
Participation involves regular check-ups and taking study medicine.

Who may be eligible?

To join this study, you must definitely not have HIV already. The study is open to cisgender men, transgender women, transgender men, and gender non-binary people. You would also need to have recently had certain types of sexual activity that can put you at a higher risk of getting HIV. This includes having had unprotected anal sex in the last year, particularly with multiple partners, or a recent sexually transmitted infection, or using certain stimulant drugs during sex.

There are also some reasons why you wouldn't be able to join. For example, if you are allergic to any of the study medicines or have an active hepatitis B infection. You also cannot have had certain cancers recently, or any long-acting HIV prevention medicines in the past. If you've been part of an HIV vaccine study or received certain antibodies in the last year, you also wouldn't be able to participate. You must also weigh at least 35 kilograms.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I do not have HIV.
I am a cisgender man, transgender woman, transgender man, or gender non-binary person.
I have had certain types of anal sex in the last 12 months.
I weigh at least 35 kilograms.
I do not have active hepatitis B.
I have not had certain cancers or specific HIV prevention medicines recently.

Answer every question to see your result.

What does participation involve?

If you join this study, you would be randomly assigned to receive either the new medicine (MK-8527) once a month, the standard daily HIV prevention medicine (FTC/TDF), or a placebo (a dummy pill) for either the monthly or daily medicine. Neither you nor the study team would know which treatment you are receiving until the end of the study. You would have regular check-ups at the clinic, which might include blood tests, urine tests, and discussions about your health and any side effects you might experience. The total duration of your participation in the study would involve several visits over a period of time, which the study team will explain in detail.

Potential risks and benefits

Taking part in this study could offer the benefit of potentially receiving an effective HIV prevention medicine. You would also be contributing to important medical research that could lead to new, more convenient options for HIV prevention for many people. However, like all medicines, MK-8527 may have side effects, and some people might receive a placebo, meaning they wouldn't be getting an active prevention medicine. There's also the chance of inconveniences from study visits and tests. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without affecting your medical care.

Locations (81)

University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 0006)
Verified postcode
Birmingham, United States· Recruiting
USA Health University Hospitals ( Site 0020)
Verified postcode
Mobile, United States· Recruiting
UCLA Center for Clinical AIDS Research and Education ( Site 0004)
Verified postcode
Los Angeles, United States· Recruiting
Bridge HIV - San Francisco Department of Public Health ( Site 0001)
Verified postcode
San Francisco, United States· Recruiting
Whitman-Walker Institute ( Site 0016)
Verified postcode
Washington D.C., United States· Recruiting
University of Miami RAPID Research ( Site 0003)
Verified postcode
Miami, United States· Recruiting
Orlando Immunology Center ( Site 0021)
Verified postcode
Orlando, United States· Recruiting
Hope Clinic of the Emory Vaccine Center ( Site 0009)
Verified postcode
Decatur, United States· Recruiting
University of Illinois Chicago ( Site 0027)
Verified postcode
Chicago, United States· Recruiting
University Medical Center New Orleans ( Site 0024)
Verified postcode
New Orleans, United States· Recruiting
Open Arms Healthcare Center ( Site 0025)
Verified postcode
Jackson, United States· Recruiting
Rutgers New Jersey Medical School ( Site 0010)
Verified postcode
Newark, United States· Recruiting

Common questions

What is HIV?

HIV (Human Immunodeficiency Virus) is a virus that can damage the body's immune system, making it harder to fight off illnesses.

What is PrEP?

PrEP stands for Pre-Exposure Prophylaxis. It's a medicine taken by people who don't have HIV to prevent them from getting it.

Will I know if I'm getting the actual medicine?

No, this is a 'blinded' study. To make the results fair, neither you nor the doctors will know who is getting the new medicine, the standard medicine, or the dummy pill.

How often would I take the new medicine?

If assigned to the new medicine, you would take one tablet once a month.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any point, and it won't affect your future medical care.

How to find out more

Toll Free Number

trialsites@msd.com 1-888-577-8839 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.