A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)

NCT07044297
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
4,390
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Lead sponsor
Merck Sharp & Dohme LLC
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Start date
2025-07-31
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Number of sites
81
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Summary
Researchers are looking for new medicines to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection. 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 prophylaxis (PrEP) taken once a day * About the safety of MK-8527 and if people tolerate it
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Short title
A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)
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Official title
A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of MK-8527 Oral Once-Monthly as HIV-1 Preexposure Prophylaxis
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2027-07-22
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First posted
2025-06-29
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Registry last updated
2026-08-24
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Primary completion date
2027-07-22
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Start date
2025-07-31
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Participants
4,390
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Participant count basis
Estimated
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Planned participants
4,390
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Protocol amendments
0
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Number of sites
81
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Merck Sharp & Dohme LLC
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07044297
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ClinicalTrials.gov ID
NCT07044297
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Number of Participants With Adjudicated Human Immunodeficiency Virus Type 1 (HIV-1) Infection

    Timeframe: Up to approximately 2 years

    The number of participants with adjudicated HIV-1 infection will be determined.

  2. Number of Participants Who Experience At Least One Adverse Event (AE)

    Timeframe: Up to approximately 2 years

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that experienced AEs will be reported.

  3. Number of Participants Who Discontinue Study Intervention Due to an AE

    Timeframe: Up to approximately 2 years

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that discontinued study intervention due to an AE will be reported.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Children, Adults, Older adults
Minimum age
16 Years
Healthy volunteers
Yes

The main inclusion criteria include but are not limited to the following:

  • Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test results
  • Is a cisgender man, transgender woman (assigned male sex at birth), transgender man (assigned female sex at birth), or gender nonbinary person
  • Has had condomless receptive anal sex in the 12 months prior to screening (not including sex occurring in a mutually monogamous relationship) and has at least 1 of the following: receptive anal sex with 2 or more partners in the 3 months prior to screening (regardless of condom use), rectal or urethral gonorrhea or chlamydia or incident syphilis in the 6 months prior to screening, or any self-reported stimulant drug use with sex in the 3 months prior to screening
  • Weighs ≥35 kg

The main exclusion criteria include but are not limited to the following:

  • Has hypersensitivity or other contraindication to any component of the study interventions
  • Has evidence of acute or chronic hepatitis B infection
  • Has a history of malignancy within 5 years of screening except for adequately treated basal cell or squamous cell skin cancer, or in situ anal or cervical cancers
  • Has taken cabotegravir, lenacapavir, or any other long-acting HIV prevention product at any time
  • Is receiving or is anticipated to require any prohibited therapies from 30 days prior to Day 1 through the study duration
  • Has received an HIV vaccine at any time (ie, through past participation in an investigational clinical study) or monoclonal antibodies to HIV within 12 months before Day 1
  • Is expecting to donate eggs at any time during the study
Sources for eligibility
clinicaltrials.gov

Sex
All
Minimum age (years)
16
Healthy volunteers
Yes

HIV-uninfected individuals assigned male or female at birth or gender nonbinary, with recent condomless receptive anal sex and at least one risk factor, weighing at least 35 kg

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

  • Is a cisgender man, transgender woman (assigned male sex at birth), transgender man (assigned female sex at birth), or gender nonbinary person

  • Has had condomless receptive anal sex in the 12 months prior to screening (not including sex occurring in a mutually monogamous relationship)

  • Has receptive anal sex with 2 or more partners in the 3 months prior to screening

    Source text: receptive anal sex with 2 or more partners in the 3 months prior to screening (regardless of condom use)

  • Has rectal or urethral gonorrhea or chlamydia or incident syphilis in the 6 months prior to screening

    Source text: rectal or urethral gonorrhea or chlamydia or incident syphilis in the 6 months prior to screening

  • Has any self-reported stimulant drug use with sex in the 3 months prior to screening

    Source text: any self-reported stimulant drug use with sex in the 3 months prior to screening

  • Weighs >=35 kg

    Source text not verified

  • Has hypersensitivity or other contraindication to any component of the study interventions

  • Has evidence of acute or chronic hepatitis B infection

  • Has a history of malignancy within 5 years of screening except for adequately treated basal cell or squamous cell skin cancer, or in situ anal or cervical cancers

  • Has taken cabotegravir, lenacapavir, or any other long-acting HIV prevention product at any time

  • Is receiving any prohibited therapies from 30 days prior to Day 1 through the study duration

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

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

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

  • Has received an HIV vaccine at any time (ie, through past participation in an investigational clinical study)

  • Has received monoclonal antibodies to HIV within 12 months before Day 1

    Source text: or monoclonal antibodies to HIV within 12 months before Day 1

  • Is expecting to donate eggs at any time during the study

  • University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 0006)Birmingham, United StatesActive, not recruiting
  • USA Health University Hospitals ( Site 0020)Mobile, United StatesActive, not recruiting
  • UCLA Center for Clinical AIDS Research and Education ( Site 0004)Los Angeles, United StatesActive, not recruiting
  • Bridge HIV - San Francisco Department of Public Health ( Site 0001)San Francisco, United StatesActive, not recruiting
  • Whitman-Walker Institute ( Site 0016)Washington D.C., United StatesActive, not recruiting
  • University of Miami RAPID Research ( Site 0003)Miami, United StatesActive, not recruiting
  • Orlando Immunology Center ( Site 0021)Orlando, United StatesActive, not recruiting
  • Hope Clinic of the Emory Vaccine Center ( Site 0009)Decatur, United StatesActive, not recruiting
  • University of Illinois Chicago ( Site 0027)Chicago, United StatesActive, not recruiting
  • University Medical Center New Orleans ( Site 0024)New Orleans, United StatesActive, not recruiting
  • Open Arms Healthcare Center ( Site 0025)Jackson, United StatesActive, not recruiting
  • Rutgers New Jersey Medical School ( Site 0010)Newark, United StatesActive, not recruiting
  • Montefiore Medical Center ( Site 0017)The Bronx, United StatesActive, not recruiting
  • NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill ( Site 0008)Chapel Hill, United StatesActive, not recruiting
  • Regional Center for Infectious Diseases ( Site 0018)Greensboro, United StatesActive, not recruiting
  • Philadelphia Fight Community Health Centers ( Site 0011)Philadelphia, United StatesActive, not recruiting
  • University of Pittsburgh Medical Center-Division of Infectious Diseases ( Site 0022)Pittsburgh, United StatesActive, not recruiting
  • Prisma Health Richland Hospital-Clinical Research Unit ( Site 0007)Columbia, United StatesActive, not recruiting
  • St. Jude Children's Research Hospital ( Site 0026)Memphis, United StatesActive, not recruiting
  • Meharry Medical College ( Site 0013)Nashville, United StatesActive, not recruiting
  • Central Texas Clinical Research ( Site 0014)Austin, United StatesActive, not recruiting
  • Saint Hope Foundation, Inc. ( Site 0015)Bellaire, United StatesActive, not recruiting
  • Fred Hutchinson Cancer Center - The Seattle HIV Vaccine Trials Unit ( Site 0002)Seattle, United StatesActive, not recruiting
  • Centro de Estudios Infectológicos S.A. ( Site 0357)CABA, ArgentinaActive, not recruiting
  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0352)CABA, ArgentinaActive, not recruiting

And 56 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • MK-8527-011
  • 2025
  • U1111-1317-6239
  • 2025-520610-58-00
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (2)