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Human Immunodeficiency Virus (HIV)Phase 3NCT07071623

A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)

A Phase 3 study testing MK-8527 and Emtricitabine/tenofovir disoproxil (FTC/TDF) in people with Human Immunodeficiency Virus (HIV) and HIV Pre-Exposure Prophylaxis, run by Merck Sharp & Dohme LLC at 30 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 16 to 30 years, women onlyHealthy volunteers can take part
What is being tested?
MK-8527 and Emtricitabine/tenofovir disoproxil (FTC/TDF)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
4,580 participants
Where
30 sitesin 3 countries
Study dates
10 Nov 2025to 18 Oct 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 30 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

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

Who cannot join

  • 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 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

Trial locations and contacts

30 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

30 sites in 3 countries

South Africa21 sites, 13 recruiting

  • Josha Research ( Site 0045)

    Bloemfontein, Free State, 9301

    Active, not recruiting

  • Desmond Tutu Health Foundation. Philippi Village ( Site 0024)

    Cape Town, Western Cape, 7781

    Study Coordinator, +27870572508

    Recruiting

  • DTHF Masiphumelele Clinical Research Site ( Site 0023)

    Cape Town, Western Cape, 7975

    Study Coordinator, +27217855454

    Recruiting

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

    Chatsworth, KwaZulu-Natal, 4092

    Active, not recruiting

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

    Durban, KwaZulu-Natal, 3660

    Active, not recruiting

  • CAPRISA eThekwini Clinical Research Site ( Site 0030)

    Durban, KwaZulu-Natal, 4001

    Active, not recruiting

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

    Durban, KwaZulu-Natal, 4001

    Study Coordinator, +27 31 001 1900

    Recruiting

  • Umlazi Clinical Research Site ( Site 0047)

    Durban, KwaZulu-Natal, 4089

    Study Coordinator, +2731 260 1982

    Recruiting

  • Synergy Biomed Research Institute ( Site 0040)

    East London, Eastern Cape, 5241

    Study Coordinator, +27437222306

    Recruiting

  • SYNAPSE Research Clinic ( Site 0043)

    Edendale, KwaZulu-Natal, 3216

    Study Coordinator, +27 73 297 2172

    Recruiting

  • Wits RHI Ward 21 Clinical Research site ( Site 0022)

    Johannesburg, Gauteng, 2001

    Study Coordinator, +27823776275

    Recruiting

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

    Johannesburg, Gauteng, 2092

    Active, not recruiting

  • Perinatal HIV Research Unit (PHRU) ( Site 0033)

    Johnnesburg, Gauteng, 1864

    Study Coordinator, +27 11 989 9711

    Recruiting

  • Vuka Research Clinic ( Site 0025)

    Khayelitsha, Western Cape, 7784

    Active, not recruiting

  • Qhakaza Mbokodo Research Clinic ( Site 0028)

    Ladysmith, KwaZulu-Natal, 3370

    Study Coordinator, +27366312372

    Recruiting

  • Foundation For Professional Development ( Site 0031)

    Ndevana, Eastern Cape, 5660

    Active, not recruiting

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

    Phoenix, KwaZulu-Natal, 4068

    Study Coordinator, +27312423632

    Recruiting

  • CAPRISA Vulindlela Clinical Research Site ( Site 0029)

    Pietermaritzburg, KwaZulu-Natal, 3231

    Study Coordinator, +2731 655 0694

    Recruiting

  • Setshaba Research Centre ( Site 0032)

    Pretoria, Gauteng, 0152

    Study Coordinator, 0127992422

    Recruiting

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

    Somkhele - Mtubatuba, KwaZulu-Natal, 3935

    Active, not recruiting

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

    Verulam, KwaZulu-Natal, 4340

    Study Coordinator, +27325334145

    Recruiting

Other trials in South Africa

Uganda5 sites, 5 recruiting

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

    Entebbe, Central Region, 256

    Study Coordinator, +256485660468

    Recruiting

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

    Entebbe, Wakiso, 30006

    Study Coordinator, +256312216100

    Recruiting

  • Infectious Diseases Institute Kalangala ( Site 0063)

    Kalangala District, Kalangala, 30060

    Study Coordinator, +256312211482

    Recruiting

  • MU-JHU Research Collaboration - Kampala ( Site 0062)

    Kampala, 10216/+256

    Study Coordinator, +256703419772

    Recruiting

  • MU-JHU Research Collaboration - Mityana ( Site 0061)

    Mityana, District, Mityana, 30026/+256

    Study Coordinator, +25760334881

    Recruiting

Other trials in Uganda

Kenya4 sites, 3 recruiting

  • UW - KNH; Rachuonyo County Hospital ( Site 0006)

    Homabay County, Homa Bay County, 40222

    Study Coordinator, +254758070947

    Recruiting

  • Kargeno Research & Policy Hub ( Site 0007)

    Kisumu, 40123

    Study Coordinator, +254732390992

    Recruiting

  • KEMRI-CMR-RCTP ( Site 0003)

    Nairobi, Kisumu County, 00200

    Study Coordinator, +254202600017

    Recruiting

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

    Thika, Kiambu County, 00202

    Active, not recruiting

Other trials in Kenya

About this study

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 in Women

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
Being tested
MK-8527, Emtricitabine/tenofovir disoproxil (FTC/TDF), Placebo matched to MK-8527, Placebo matched to FTC/TDF
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MK-8527Drug

    Oral tablet

  • Emtricitabine/tenofovir disoproxil (FTC/TDF)Drug

    Also called Truvada, Emtricitabine/Tenofovir Disoproxil Fumarate

    Oral tablet

  • Placebo matched to MK-8527Drug

    Placebo oral tablet matched to MK-8527

  • Placebo matched to FTC/TDFDrug

    Placebo oral tablet matched to FTC/TDF

Study groups in NCT07071623
Study groupRoleWhat they receive
MK-8527 + Placebo to FTC/TDFExperimentalParticipants 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.
Receives: Drug: MK-8527; Drug: Placebo matched to FTC/TDF
FTC/TDF + Placebo to MK-8527Active comparatorParticipants 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.
Receives: Drug: Emtricitabine/tenofovir disoproxil (FTC/TDF); Drug: Placebo matched to MK-8527

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to ~2 years

  2. 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.

    Measured: Up to ~2 years

  3. 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.

    Measured: Up to ~2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2025
  2. Study start10 Nov 2025
  3. Primary completion18 Oct 2027 (estimated)
  4. Study completion18 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
4,580 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07071623
Sponsor's protocol ID
8527-010
Other IDs
MK-8527-010
Status last verified
Oct 2026
First submitted
8 Jul 2025
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MK-8527 and Emtricitabine/tenofovir disoproxil (FTC/TDF) in people with Human Immunodeficiency Virus (HIV) and HIV Pre-Exposure Prophylaxis, run by Merck Sharp & Dohme LLC at 30 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in South Africa, Uganda, Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adjudicated Human Immunodeficiency Virus Type 1 (HIV-1) Infection (time frame: Up to ~2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07071623.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

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