MK-8527 for HIV Prevention

No longer recruiting at 19 trial locations

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Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Merck Sharp & Dohme LLC

Disqualifiers: Hepatitis, Prior MK-8527, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medication, MK-8527, to determine its effectiveness in preventing HIV (human immunodeficiency virus) infection. Participants take the medication once a month, and researchers study its safety, tolerability, and behavior in the body. Participants will be divided into groups receiving a high, medium, or low dose of the drug, or a placebo (a pill with no active drug). The trial seeks individuals who are currently HIV-negative and at low risk for infection. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

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

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

Research has shown that MK-8527 is generally safe and well-tolerated. In one study, participants taking MK-8527 reported no serious side effects. The drug's action in the body increased predictably with the dose, suggesting it doesn't cause unexpected reactions. Researchers have tested the safety of MK-8527 in people without HIV, providing some confidence in its use for HIV prevention. However, ongoing studies will continue to monitor its safety as more people use it. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Most treatments for HIV prevention, like PrEP (pre-exposure prophylaxis), require daily medication. But MK-8527 is different because it offers a potentially less frequent dosing schedule, with participants taking it once a month. This monthly oral administration could improve adherence by reducing the daily pill burden. Researchers are excited because this could make it easier for people to consistently use the medication, thereby enhancing its effectiveness in preventing HIV.

What evidence suggests that this trial's treatments could be effective for HIV prevention?

Research has shown that MK-8527 can help prevent HIV-1 infection by blocking a protein called reverse transcriptase, which the virus needs to reproduce. Early studies found that MK-8527 stops this protein, preventing the virus from spreading. Previous trials showed that the drug is safe for adults who do not have HIV. These findings suggest that MK-8527 could be a promising option for preventing HIV-1. Participants in this trial will receive different doses of MK-8527 or a placebo to further evaluate its effectiveness and safety. ^{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 low risk of HIV-1 infection who have tested negative for HIV. Men must use contraception or abstain from penile-vaginal intercourse if they can produce sperm, and women should not be pregnant, breastfeeding, and must either use effective contraception or abstain if they are capable of childbearing.

Inclusion Criteria

Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test result before randomization

Has low-risk of HIV infection

I am not pregnant or breastfeeding, and if I can have children, I use birth control or abstain from sex.

Exclusion Criteria

I have an active hepatitis infection.

Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator

I have previously taken MK-8527 or islatravir (MK-8591).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral MK-8527 or placebo once monthly for 6 months

24 weeks

Monthly visits for dosing

Blinded Safety Follow-up

Participants are monitored for safety and tolerability after treatment

8 weeks

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• MK-8527

Trial Overview The study is testing the safety and how the body processes a once-monthly oral pill called MK-8527 compared to a placebo (a pill with no active drug) in people at low risk for HIV-1. Participants won't know whether they're getting MK-8527 or the placebo.

How Is the Trial Designed?

Group I: MK-8527 Medium Dose QM Experimental Treatment 1 Intervention

Participants receive oral MK-8527 medium dose QM for 6 months, followed by an 8-week blinded safety follow-up period.

Group II: MK-8527 Low Dose QM Experimental Treatment 1 Intervention

Participants receive oral MK-8527 low dose QM for 6 months, followed by an 8-week blinded safety follow-up period.

Group III: MK-8527 High Dose QM Experimental Treatment 1 Intervention

Participants receive oral MK-8527 high dose QM for 6 months, followed by an 8-week blinded safety follow-up period.

Group IV: Placebo to MK-8527 Placebo Group 1 Intervention

Participants receive oral placebo matched to MK-8527 QM for 6 months, followed by an 8-week blinded safety follow-up period.

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

Published Research Related to This Trial

MK-8389 was found to be generally safe and well tolerated in healthy young women over a 14-day period, although it caused transient changes in thyroid function tests that limited dose escalation above 40 mg.

While MK-8389 showed acceptable systemic exposure, it did not have a clinically meaningful effect on follicular development, although higher doses did increase inhibin B levels, indicating some early follicular activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral follicle-stimulating hormone agonist tested in healthy young women of reproductive age failed to demonstrate effect on follicular development but affected thyroid function. Gerrits, MG., Kramer, H., el Galta, R., et al.[2016]

MK-8591, an investigational drug for HIV treatment, shows promise for long-acting formulations that could improve adherence to treatment regimens, as it maintains effective drug levels for over 6 months after subcutaneous implantation in animal studies.

The drug's active form, MK-8591-TP, demonstrates prolonged intracellular persistence and significant viral load reduction, indicating its potential effectiveness for both treatment and pre-exposure prophylaxis (PrEP) against HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended-Duration MK-8591-Eluting Implant as a Candidate for HIV Treatment and Prevention. Barrett, SE., Teller, RS., Forster, SP., et al.[2020]

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. 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 ...

4. 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 ...

5. merck.com merck.com/news/merck-to-present-new-data-from-hiv-treatment-and-prevention-pipeline-at-european-aids-conference-2025/

Merck to Present New Data from HIV Treatment and ... Patient-Reported Outcomes From People With HIV-1 Receiving Once-Weekly Oral Islatravir in Combination With Lenacapavir: Phase 2 Week 48 Results.

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 ...