MK-8527 for HIV Prevention

Recruiting at 41 trial locations

Overseen By Toll Free Number

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Merck Sharp & Dohme LLC

Must not be taking: Cabotegravir, Lenacapavir, others

Disqualifiers: Hepatitis B, Recent malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to approximately 2 years

4390 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medicine, MK-8527, a potential HIV prevention drug, to determine if a monthly dose can prevent HIV-1 infection as effectively as the standard daily prevention pill. Researchers aim to assess whether MK-8527 is safe and easy for people to take. Suitable participants include those confirmed to be HIV-negative who have recently engaged in condomless receptive anal sex and have certain risk factors, such as multiple partners or recent sexually transmitted infections. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking HIV prevention method.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but it mentions that you cannot take certain prohibited therapies from 30 days before the study starts and throughout its duration.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that MK-8527 is safe and generally well-tolerated. Previous studies found no serious side effects, and participants reported no major problems. The studies also demonstrated that the drug's effects increased predictably with higher doses, a positive sign for safety. These results suggest that MK-8527 could be a promising option for preventing HIV-1 infection. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for HIV?

Researchers are excited about MK-8527 for HIV prevention because it offers a new, less frequent dosing schedule compared to the daily pills that are currently standard, like FTC/TDF (Truvada). MK-8527 is administered once a month, which could significantly improve adherence for many people. This new approach could make staying protected against HIV much easier and more convenient, reducing the daily burden of taking medication.

What evidence suggests that MK-8527 might be an effective treatment for HIV prevention?

Research has shown that MK-8527, which participants in this trial may receive, could be a promising new method to prevent HIV-1 infection. This medication blocks an enzyme the virus needs to multiply in the body. Early results suggest that taking MK-8527 once a month could be more convenient than daily pills for HIV prevention. Previous studies have found that MK-8527 is generally well-tolerated, with side effects similar to those of a placebo (a harmless pill used for comparison). Although the study is ongoing, early data supports its potential effectiveness in preventing HIV. ^{3 4 6 7 8}

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for individuals at risk of HIV-1 who haven't contracted the virus. Participants should be healthy and willing to take medication as a preventive measure (PrEP). Specific criteria for joining or reasons for exclusion aren't provided, but typically include factors like age, health status, and potential risks.

Inclusion Criteria

I identify as a cisgender man, transgender woman, transgender man, or nonbinary.

I have had unprotected sex and meet at least one of the listed risk factors recently.

Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test results

Exclusion Criteria

Has evidence of acute or chronic hepatitis B infection

I haven't had cancer in the last 5 years, except for certain skin cancers or in situ anal or cervical cancers.

Is receiving or is anticipated to require any prohibited therapies from 30 days prior to Day 1 through the study duration

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either MK-8527 once monthly or FTC/TDF once daily for up to approximately 2 years

Up to approximately 2 years

Open-label extension

Participants receive open-label FTC/TDF once daily for an additional 28 days

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MK-8527

Trial Overview The study compares MK-8527, a new drug taken once a month, with FTC/TDF—a standard daily PrEP regimen—to prevent HIV-1 infection. It also tests placebos against both drugs to check their effectiveness and safety.

How Is the Trial Designed?

Group I: MK-8527 Experimental Treatment 3 Interventions

Participants will receive 11 mg MK-8527 once monthly (QM) and placebo to FTC/TDF once daily (QD) for up to approximately 2 years. Participants will then receive open-label 200 mg FTC/245 mg TDF QD for an additional 28 days.

Group II: FTC/TDF Active Control 2 Interventions

Participants will receive 200 mg FTC/245 mg TDF QD and placebo to MK-8527 QM for up to approximately 2 years. Participants will then receive open-label 200 mg FTC/245 mg TDF QD for an additional 28 days.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07044297

NCT07044297 | A Clinical Study of MK-8527 to Prevent ... The goals of this study are to learn: If taking MK-8527 once a month works to prevent HIV-1 infection as well as or better than a standard (usual) pre-exposure ...

2. merck.com merck.com/news/merck-to-initiate-phase-3-trials-for-investigational-once-monthly-hiv-prevention-pill/

Merck to Initiate Phase 3 Trials for Investigational Once ... The primary objective of the study is to evaluate the efficacy, safety, and tolerability of once-monthly oral MK-8527 compared to daily ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12435975/

Safety and Pharmacokinetics of MK‐8527 in Adults Without ... Two Phase 1 trials evaluated single (trial A) and multiple (trial B) ascending doses of MK‐8527 in adults without HIV.

4. journals.plos.org journals.plos.org/plosbiology/article?id=10.1371/journal.pbio.3003308

MK-8527 is a novel inhibitor of HIV-1 reverse transcriptase ... MK-8527-TP directly inhibits HIV-1 RT​​ To verify that the antiviral effects of MK-8527 were a result of direct inhibition of HIV-1 RT, MK-8527-TP was evaluated ...

5. aidsmap.com aidsmap.com/bulletin/conference-news/ias-2025/18-july-2025

IAS 2025: Monthly oral PrEP pill advances to phase III trials ... The study found MK-8527 was well tolerated across all dose levels with a safety profile similar to placebo. The most common side effects were ...

6. prepwatch.org prepwatch.org/products/mk-8527/

MK-8527 Found to be safe and well-tolerated in a Phase II clinical trial. Two Phase III clinical trials, due to start enrolling in August 2025, will investigate ...

7. ascpt.onlinelibrary.wiley.com ascpt.onlinelibrary.wiley.com/doi/full/10.1111/cts.70331

Safety and Pharmacokinetics of MK‐8527 in Adults Without HIV MK-8527 was generally well tolerated with no serious adverse events. Plasma exposure of MK-8527 increased approximately dose-proportionally, and ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12380353/

MK-8527 is a novel inhibitor of HIV-1 reverse transcriptase ... MK-8527 potently inhibited HIV replication, with an IC50 of 0.21 nM against HIV-1 in PBMCs, similar to the previously reported IC50 of ISL ...