NCT07071623

Brief 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 better than a standard (usual) pre-exposure prophylaxis (PrEP) taken once a day
  • About the safety of MK-8527 and if people tolerate it

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,580

participants targeted

Target at P75+ for phase_3

Timeline
18mo left

Started Nov 2025

Geographic Reach
3 countries

30 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Nov 2025Oct 2027

First Submitted

Initial submission to the registry

July 8, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 17, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

November 10, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2027

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

1.9 years

First QC Date

July 8, 2025

Last Update Submit

April 30, 2026

Conditions

HIV Pre-Exposure ProphylaxisHuman Immunodeficiency Virus (HIV)

Outcome Measures

Primary Outcomes (3)

  • Number of Participants with Adjudicated Human Immunodeficiency Virus Type 1 (HIV-1) Infection

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

    Up to ~2 years

  • Number of Participants who Experience At Least One Adverse Event (AE)

    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 presented.

    Up to ~2 years

  • Number of Participants who Discontinue Study Intervention Due to an AE

    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 presented.

    Up to ~2 years

Study Arms (2)

MK-8527 + Placebo to FTC/TDF

EXPERIMENTAL

Participants will receive 11 mg MK-8527 once monthly (QM) and placebo matched to Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) once daily (QD) for up to approximately 2 years. Participants will then receive open-label 200 mg FTC/245 mg TDF QD for an additional 28 days.

Drug: MK-8527Drug: Placebo matched to FTC/TDF

FTC/TDF + Placebo to MK-8527

ACTIVE COMPARATOR

Participants will receive 200 mg FTC/245 mg TDF QD and placebo matched to MK-8527 QM for up to approximately 2 years. Participants will then receive open-label 200 mg FTC/245 mg TDF QD for an additional 28 days.

Drug: Emtricitabine/tenofovir disoproxil (FTC/TDF)Drug: Placebo matched to MK-8527

Interventions

MK-8527DRUG

Oral tablet

MK-8527 + Placebo to FTC/TDF
Emtricitabine/tenofovir disoproxil (FTC/TDF)DRUG

Oral tablet

Also known as: Truvada, Emtricitabine/Tenofovir Disoproxil Fumarate
FTC/TDF + Placebo to MK-8527
Placebo matched to MK-8527DRUG

Placebo oral tablet matched to MK-8527

FTC/TDF + Placebo to MK-8527
Placebo matched to FTC/TDFDRUG

Placebo oral tablet matched to FTC/TDF

MK-8527 + Placebo to FTC/TDF

Eligibility Criteria

Age16 Years - 30 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipants must be assigned female sex at birth and cisgender.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Is confirmed Human Immunodeficiency Virus (HIV)-uninfected based on negative HIV-1/HIV-2 test results
  • Has been sexually active (2 vaginal intercourse encounters with cisgender male individual(s) within the last 3 months)
  • Was assigned female sex at birth and is cisgender.
  • Weighs ≥35 kg

You may not qualify if:

  • 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 cervical cancer
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

UW - KNH; Rachuonyo County Hospital ( Site 0006)

Homabay County, Homa Bay County, 40222, Kenya

RECRUITING

Partners in Health and Research Development (PHRD) ( Site 0002)

Thika, Kiambu County, 00202, Kenya

RECRUITING

KEMRI-CMR-RCTP ( Site 0003)

Nairobi, Kisumu County, 00200, Kenya

RECRUITING

Kargeno Research & Policy Hub ( Site 0007)

Kisumu, 40123, Kenya

RECRUITING

Synergy Biomed Research Institute ( Site 0040)

East London, Eastern Cape, 5241, South Africa

RECRUITING

Foundation For Professional Development ( Site 0031)

Ndevana, Eastern Cape, 5660, South Africa

RECRUITING

Josha Research ( Site 0045)

Bloemfontein, Free State, 9301, South Africa

RECRUITING

Wits RHI Ward 21 Clinical Research site ( Site 0022)

Johannesburg, Gauteng, 2001, South Africa

RECRUITING

Helen Joseph Hospital-Clinical HIV Research Unit ( Site 0048)

Johannesburg, Gauteng, 2092, South Africa

RECRUITING

Perinatal HIV Research Unit (PHRU) ( Site 0033)

Johnnesburg, Gauteng, 1864, South Africa

RECRUITING

Setshaba Research Centre ( Site 0032)

Pretoria, Gauteng, 0152, South Africa

RECRUITING

SA Medical Research Council - Chatsworth Clinical Research Site ( Site 0026)

Chatsworth, KwaZulu-Natal, 4092, South Africa

RECRUITING

SA Medical Research Council - Botha's Hill Clinical Research Site ( Site 0035)

Durban, KwaZulu-Natal, 3660, South Africa

RECRUITING

CAPRISA eThekwini Clinical Research Site ( Site 0030)

Durban, KwaZulu-Natal, 4001, South Africa

RECRUITING

Wits Maternal Adolescent and Child Health Research Unit (WMRU) ( Site 0027)

Durban, KwaZulu-Natal, 4001, South Africa

RECRUITING

Umlazi Clinical Research Site ( Site 0047)

Durban, KwaZulu-Natal, 4089, South Africa

RECRUITING

SYNAPSE Research Clinic ( Site 0043)

Edendale, KwaZulu-Natal, 3216, South Africa

RECRUITING

Qhakaza Mbokodo Research Clinic ( Site 0028)

Ladysmith, KwaZulu-Natal, 3370, South Africa

RECRUITING

SA Medical Research Council - Phoenix Clinical Research Site ( Site 0037)

Phoenix, KwaZulu-Natal, 4068, South Africa

RECRUITING

CAPRISA Vulindlela Clinical Research Site ( Site 0029)

Pietermaritzburg, KwaZulu-Natal, 3231, South Africa

RECRUITING

Africa Health Research Institute (AHRI) - Mtubatuba ( Site 0049)

Somkhele - Mtubatuba, KwaZulu-Natal, 3935, South Africa

RECRUITING

SA Medical Research Council - Verulam Clinical Research Site ( Site 0036)

Verulam, KwaZulu-Natal, 4340, South Africa

RECRUITING

Desmond Tutu Health Foundation. Philippi Village ( Site 0024)

Cape Town, Western Cape, 7781, South Africa

RECRUITING

DTHF Masiphumelele Clinical Research Site ( Site 0023)

Cape Town, Western Cape, 7795, South Africa

RECRUITING

Vuka Research Clinic ( Site 0025)

Khayelitsha, Western Cape, 7784, South Africa

RECRUITING

MRC/UVRI and LSHTM Uganda Research Unit Masaka ( Site 0064)

Entebbe, Central Region, 256, Uganda

RECRUITING

Infectious Diseases Institute Kalangala ( Site 0063)

Kalangala District, Kalangala, 30060/+256, Uganda

RECRUITING

MU-JHU Research Collaboration - Mityana ( Site 0061)

Mityana, District, Mityana, 30026/+256, Uganda

RECRUITING

UVRI Clinical Research Program Initiative Ltd (UVRI CRP) ( Site 0067)

Entebbe, Wakiso, 30006, Uganda

RECRUITING

MU-JHU Research Collaboration - Kampala ( Site 0062)

Kampala, 10216/+256, Uganda

RECRUITING

Related Links

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

EmtricitabineTenofovirEmtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDrug CombinationsPharmaceutical Preparations

Study Officials

  • Medical Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839Trialsites@msd.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2025

First Posted

July 17, 2025

Study Start

November 10, 2025

Primary Completion (Estimated)

October 18, 2027

Study Completion (Estimated)

October 18, 2027

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

More information

Locations

UG(5)KE(4)ZA(21)