MK-8527 for HIV Prevention

Recruiting at 18 trial locations

Overseen By Toll Free Number

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

352 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a pill called MK-8527 in people who are unlikely to get HIV-1 to see if it is safe and how their bodies handle it.

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.

What data supports the effectiveness of the drug MK-8527 for HIV prevention?

Research on similar drugs like MK-8507 and MK-8591 shows they have strong potential for HIV treatment and prevention. MK-8507 has been shown to suppress HIV for a week with a single dose, and MK-8591 has demonstrated long-lasting effects in animal studies, suggesting that MK-8527 might also be effective for HIV prevention. ^{1 2 3 4 5}

Is MK-8527 safe for humans?

MK-8507, a similar drug, was tested in adults without HIV and was generally well tolerated with no significant changes in vital signs or lab tests. This suggests it may be safe for humans, but more research is needed to confirm this for MK-8527 specifically. ^{1 2 3 5 6}

What makes the drug MK-8527 unique for HIV prevention?

MK-8527 is unique because it is a long-acting drug that can be administered less frequently, potentially improving adherence compared to daily oral regimens. It is similar to MK-8591, which is being studied for its ability to release the drug over an extended period, making it a promising option for HIV prevention. ^{1 2 3 4 7}

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Single Oral Doses of MK-8507, a Novel Non-Nucleoside Reverse Transcriptase Inhibitor, Suppress HIV-1 RNA for a Week. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Extended-Duration MK-8591-Eluting Implant as a Candidate for HIV Treatment and Prevention. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Pharmacokinetic and Safety Profile of the Novel HIV Nonnucleoside Reverse Transcriptase Inhibitor MK-8507 in Adults without HIV. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Single oral dose of maraviroc does not prevent ex-vivo HIV infection of rectal mucosa in HIV-1 negative human volunteers. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Antiretroviral activity, pharmacokinetics, and tolerability of MK-0518, a novel inhibitor of HIV-1 integrase, dosed as monotherapy for 10 days in treatment-naive HIV-1-infected individuals. [2020]

6. United States 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. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Safety and Tolerability of Maraviroc-Containing Regimens to Prevent HIV Infection in Women: A Phase 2 Randomized Trial. [2022]