Actively Recruiting

Phase 3
Age: 16Years - 30Years
FEMALE
Healthy Volunteers
NCT07071623

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

Led by Merck Sharp & Dohme LLC · Updated on 2026-05-04

4580

Participants Needed

30

Research Sites

101 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 16Years - 30Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed HIV-uninfected with negative HIV-1/HIV-2 test results
  • Sexually active with at least 2 vaginal intercourse encounters with cisgender male(s) in the last 3 months
  • Assigned female sex at birth and is cisgender
  • Weighs at least 35 kilograms
Not Eligible

You will not qualify if you...

  • Allergic or sensitive to any component of the study drugs
  • Has acute or chronic hepatitis B infection
  • Has had cancer within the last 5 years except for treated basal or squamous cell skin cancer or in situ cervical cancer
  • Has used cabotegravir, lenacapavir, or any other long-acting HIV prevention product before
  • Is using or needs prohibited therapies from 30 days before the study start through the study
  • Has received an HIV vaccine or monoclonal antibodies to HIV within 12 months before the study start

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 30 locations

1

UW - KNH; Rachuonyo County Hospital ( Site 0006)

Homabay County, Homa Bay County, Kenya, 40222

Actively Recruiting

2

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

Thika, Kiambu County, Kenya, 00202

Actively Recruiting

3

KEMRI-CMR-RCTP ( Site 0003)

Nairobi, Kisumu County, Kenya, 00200

Actively Recruiting

4

Kargeno Research & Policy Hub ( Site 0007)

Kisumu, Kenya, 40123

Actively Recruiting

5

Synergy Biomed Research Institute ( Site 0040)

East London, Eastern Cape, South Africa, 5241

Actively Recruiting

6

Foundation For Professional Development ( Site 0031)

Ndevana, Eastern Cape, South Africa, 5660

Actively Recruiting

7

Josha Research ( Site 0045)

Bloemfontein, Free State, South Africa, 9301

Actively Recruiting

8

Wits RHI Ward 21 Clinical Research site ( Site 0022)

Johannesburg, Gauteng, South Africa, 2001

Actively Recruiting

9

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

Johannesburg, Gauteng, South Africa, 2092

Actively Recruiting

10

Perinatal HIV Research Unit (PHRU) ( Site 0033)

Johnnesburg, Gauteng, South Africa, 1864

Actively Recruiting

11

Setshaba Research Centre ( Site 0032)

Pretoria, Gauteng, South Africa, 0152

Actively Recruiting

12

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

Chatsworth, KwaZulu-Natal, South Africa, 4092

Actively Recruiting

13

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

Durban, KwaZulu-Natal, South Africa, 3660

Actively Recruiting

14

CAPRISA eThekwini Clinical Research Site ( Site 0030)

Durban, KwaZulu-Natal, South Africa, 4001

Actively Recruiting

15

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

Durban, KwaZulu-Natal, South Africa, 4001

Actively Recruiting

16

Umlazi Clinical Research Site ( Site 0047)

Durban, KwaZulu-Natal, South Africa, 4089

Actively Recruiting

17

SYNAPSE Research Clinic ( Site 0043)

Edendale, KwaZulu-Natal, South Africa, 3216

Actively Recruiting

18

Qhakaza Mbokodo Research Clinic ( Site 0028)

Ladysmith, KwaZulu-Natal, South Africa, 3370

Actively Recruiting

19

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

Phoenix, KwaZulu-Natal, South Africa, 4068

Actively Recruiting

20

CAPRISA Vulindlela Clinical Research Site ( Site 0029)

Pietermaritzburg, KwaZulu-Natal, South Africa, 3231

Actively Recruiting

21

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

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

Actively Recruiting

22

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

Verulam, KwaZulu-Natal, South Africa, 4340

Actively Recruiting

23

Desmond Tutu Health Foundation. Philippi Village ( Site 0024)

Cape Town, Western Cape, South Africa, 7781

Actively Recruiting

24

DTHF Masiphumelele Clinical Research Site ( Site 0023)

Cape Town, Western Cape, South Africa, 7795

Actively Recruiting

25

Vuka Research Clinic ( Site 0025)

Khayelitsha, Western Cape, South Africa, 7784

Actively Recruiting

26

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

Entebbe, Central Region, Uganda, 256

Actively Recruiting

27

Infectious Diseases Institute Kalangala ( Site 0063)

Kalangala District, Kalangala, Uganda, 30060/+256

Actively Recruiting

28

MU-JHU Research Collaboration - Mityana ( Site 0061)

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

Actively Recruiting

29

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

Entebbe, Wakiso, Uganda, 30006

Actively Recruiting

30

MU-JHU Research Collaboration - Kampala ( Site 0062)

Kampala, Uganda, 10216/+256

Actively Recruiting

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Research Team

T

Toll Free Number

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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