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Antiretroviral Agent

MK-8527 for HIV Prevention

Q: To what demographic does this research endeavor pertain?

<p>This scientific trial is open to 350 <a href="https://www.withpower.com/clinical-trials/hiv">HIV</a>/<a href="https://www.withpower.com/clinical-trials/aids">AIDS</a> patients aged 18-65. Furthermore, applicants should meet the following conditions: have a confirmed negative HIV test result; be at low risk of infection; males must abstain from penile-vaginal intercourse or use contraception if producing sperm during intervention and 8 weeks after last dose of study drug; females cannot be pregnant or breastfeeding, and must use highly effective contraception or abstain from sexual intercourse.</p>

Q: What is the cap on recruitment for this medical trial?

<p>Merck Sharp &#x26; Dohme LLC have mandated that 350 participants meeting the trial's criteria need to be enrolled in order for it to commence. Such enrolment will take place at Velocity Clinical Research, Rockville (Site 0048) of <a href="https://www.withpower.com/clinical-trials/maryland">Maryland</a> and Velocity Clinical Research, Hallandale Beach ( Site 0052) of <a href="https://www.withpower.com/clinical-trials/florida">Florida</a>.</p>

Phase 2

Recruiting

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1: predose and 0.5, 4, and 24 hours postdose. week 20: 0.5, 4, and 24 hours postdose

Awards & highlights

Study Summary

This trial tests a drug to see if it's safe and effective to prevent HIV infection in people at low risk.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects of MK-8527 aren't detailed here but typically include reactions where pills are processed in the body such as stomach issues, potential allergic reactions, or other symptoms that will be closely monitored.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1: predose and 0.5, 4, and 24 hours postdose. week 20: 0.5, 4, and 24 hours postdose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1: predose and 0.5, 4, and 24 hours postdose. week 20: 0.5, 4, and 24 hours postdose

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1: predose and 0.5, 4, and 24 hours postdose. week 20: 0.5, 4, and 24 hours postdose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants Discontinuing From Study Therapy Due to AE

Number of Participants With ≥1 Adverse Event (AE)

Secondary outcome measures

Area Under the Plasma Concentration-Time Curve From Dosing to Last Measurable Concentration (AUC0-last) of MK-8527

Maximum Plasma Concentration (Cmax) of MK-8527

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: MK-8527 Medium Dose QMExperimental Treatment1 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 QMExperimental Treatment1 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 QMExperimental Treatment1 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-8527Placebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MK-8527

2019

Completed Phase 1

~40

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor

3,892 Previous Clinical Trials

5,060,796 Total Patients Enrolled

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,063,869 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings for new participants in this medical experiment?

"The investigation, which was introduced to clinicaltrials.gov on the 8th of November 2023 and recently updated on the 15th of that same month, is currently recruiting participants."

Answered by AI

In which areas are participants able to access this clinical trial?

"Velocity Clinical Research, Rockville (Site 0048), Velocity Clinical Research, Hallandale Beach (Site 0052) and Community Medical Care Center( Site 0056) in Immokalee are just 3 of the 10 different medical centres currently recruiting for this trial."

Answered by AI

Does this medical trial include minors as possible participants?

"Applicants within the age range of 18 and 65 are eligible for this clinical trial. For those under 18, there are 248 different trials with their own criteria while 795 studies accept patients over 65 years old."

Answered by AI

Has the FDA given its stamp of approval to MK-8527 Low Dose QM?

"Assuming MK-8527 Low Dose QM's safety, our team gave it a score of 2 to reflect that this is only a Phase 2 trial. This implies there are some pieces of data confirming the drug's safety but none yet supporting its efficacy."

Answered by AI

To what demographic does this research endeavor pertain?

"This scientific trial is open to 350 HIV/AIDS patients aged 18-65. Furthermore, applicants should meet the following conditions: have a confirmed negative HIV test result; be at low risk of infection; males must abstain from penile-vaginal intercourse or use contraception if producing sperm during intervention and 8 weeks after last dose of study drug; females cannot be pregnant or breastfeeding, and must use highly effective contraception or abstain from sexual intercourse."

Answered by AI

What is the cap on recruitment for this medical trial?

"Merck Sharp & Dohme LLC have mandated that 350 participants meeting the trial's criteria need to be enrolled in order for it to commence. Such enrolment will take place at Velocity Clinical Research, Rockville (Site 0048) of Maryland and Velocity Clinical Research, Hallandale Beach ( Site 0052) of Florida."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Pharmacokinetic Study of Oral MK-8527 QM in Participants at Low-Risk for HIV-1 Infection (MK-8527-007)

2023. "Safety and Pharmacokinetic Study of Oral MK-8527 QM in Participants at Low-Risk for HIV-1 Infection (MK-8527-007)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06045507.

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