MK-8527 for HIV Prevention

Not currently recruiting at 1 trial location

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Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Merck Sharp & Dohme LLC

Disqualifiers: Cancer, Hepatitis B, Hepatitis C, HIV, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medicine, MK-8527, which could simplify HIV-1 prevention by requiring just one tablet a month. The trial aims to determine if a higher dose of MK-8527 affects heart rhythm, a crucial safety factor. Participants may receive MK-8527, a standard antibiotic called moxifloxacin, and a placebo (inactive pill) for comparison. Individuals who are generally healthy and have a BMI between 18 and 32 may be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Studies have shown that MK-8527 is generally safe and well-tolerated in people. Earlier research reported no serious side effects. Researchers tested the treatment in adults without HIV, and it was well-tolerated, meaning people could take it without major issues. So far, MK-8527 has passed safety checks in more advanced studies as well. Researchers continue to investigate its long-term safety, but current evidence is promising for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for HIV prevention, which typically include antiretroviral therapies like Truvada or Descovy, MK-8527 offers a fresh approach. Researchers are excited because MK-8527 potentially works through a novel mechanism that could provide another layer of protection against HIV. While current options mainly focus on inhibiting viral replication, MK-8527 might target the virus in a new way, possibly improving effectiveness or reducing side effects. This could be a game changer in providing more comprehensive and accessible prevention strategies.

What evidence suggests that MK-8527 might be an effective treatment for HIV-1 prevention?

Research has shown that MK-8527 could be a promising method to prevent HIV-1 infection. This medication blocks an enzyme essential for the virus's growth. Early results suggest that MK-8527 is safe and has few side effects, comparable to a placebo. Unlike current prevention pills that require daily intake, MK-8527 is taken just once a month. The trial will evaluate MK-8527 in various combinations, including with moxifloxacin and placebo, to assess its effectiveness and safety in different contexts. This approach could simplify adherence to prevention plans. ^{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 healthy adults who may participate in testing a new medication, MK-8527, intended as a once-a-month oral tablet to prevent HIV-1 infection. Specific eligibility criteria are not provided but typically include factors like age range and overall health status.

Inclusion Criteria

Is in good health before randomization

My BMI is between 18 and 32.

Exclusion Criteria

Has positive test(s) for hepatitis C antibodies

Has history of clinically significant endocrine abnormalities

I have had serious stomach or intestine problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of MK-8527, moxifloxacin, and placebo depending on randomization

1 day

1 visit (in-person)

Monitoring

Blood samples collected at multiple time points to estimate pharmacokinetic parameters and monitor QTc interval

7 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 is examining the safety of MK-8527, particularly its effect on heart rhythm (QT interval) when taken at higher doses. It's compared with Moxifloxacin (an antibiotic known to affect heart rhythm) and a placebo in a controlled environment.

How Is the Trial Designed?

Group I: Placebo PLUS MK-8527 and Moxifloxacin Experimental Treatment 3 Interventions

Participants receive a single dose of placebo followed by a single dose of MK-8527 and a single dose of moxifloxacin depending on randomization.

Group II: Moxifloxacin PLUS MK-8527 and Placebo Experimental Treatment 3 Interventions

Participants receive a single dose of moxifloxacin followed by a single dose of MK-8527 and a single dose of placebo depending on randomization.

Group III: MK-8527 PLUS Moxifloxacin and Placebo Experimental Treatment 3 Interventions

Participants receive a single dose of MK-8527 followed by a single dose of moxifloxacin and a single dose of placebo depending on randomization.

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. 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 ...

2. 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.

3. 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 ...

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 ...