A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)
Recruiting · NCT07071623 · Interventional (participants receive a specific treatment) · Lead sponsor: Merck Sharp & Dohme LLC
View the official record on ClinicalTrials.gov →Interventions studied
Emtricitabine/tenofovir disoproxil (FTC/TDF)MK-8527Placebo matched to FTC/TDFPlacebo matched to MK-8527
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
Who can take part
Age range
16 Years to 30 Years
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
Where it is running
30 locations listed.
- MU-JHU Research Collaboration - Kampala ( Site 0062) - Kampala, Uganda
- Kargeno Research & Policy Hub ( Site 0007) - Kisumu, Kenya
- MRC/UVRI and LSHTM Uganda Research Unit Masaka ( Site 0064) - Entebbe, Central Region, Uganda
- Synergy Biomed Research Institute ( Site 0040) - East London, Eastern Cape, South Africa
- Foundation For Professional Development ( Site 0031) - Ndevana, Eastern Cape, South Africa
- Josha Research ( Site 0045) - Bloemfontein, Free State, South Africa
- Wits RHI Ward 21 Clinical Research site ( Site 0022) - Johannesburg, Gauteng, South Africa
- Helen Joseph Hospital-Clinical HIV Research Unit ( Site 0048) - Johannesburg, Gauteng, South Africa
- Perinatal HIV Research Unit (PHRU) ( Site 0033) - Johnnesburg, Gauteng, South Africa
- Setshaba Research Centre ( Site 0032) - Pretoria, Gauteng, South Africa
- UW - KNH; Rachuonyo County Hospital ( Site 0006) - Homabay County, Homa Bay County, Kenya
- Infectious Diseases Institute Kalangala ( Site 0063) - Kalangala District, Kalangala, Uganda
- Partners in Health and Research Development (PHRD) ( Site 0002) - Thika, Kiambu County, Kenya
- KEMRI-CMR-RCTP ( Site 0003) - Nairobi, Kisumu County, Kenya
- SA Medical Research Council - Chatsworth Clinical Research Site ( Site 0026) - Chatsworth, KwaZulu-Natal, South Africa
- SA Medical Research Council - Botha's Hill Clinical Research Site ( Site 0035) - Durban, KwaZulu-Natal, South Africa
- CAPRISA eThekwini Clinical Research Site ( Site 0030) - Durban, KwaZulu-Natal, South Africa
- Wits Maternal Adolescent and Child Health Research Unit (WMRU) ( Site 0027) - Durban, KwaZulu-Natal, South Africa
- Umlazi Clinical Research Site ( Site 0047) - Durban, KwaZulu-Natal, South Africa
- SYNAPSE Research Clinic ( Site 0043) - Edendale, KwaZulu-Natal, South Africa
- Qhakaza Mbokodo Research Clinic ( Site 0028) - Ladysmith, KwaZulu-Natal, South Africa
- SA Medical Research Council - Phoenix Clinical Research Site ( Site 0037) - Phoenix, KwaZulu-Natal, South Africa
- CAPRISA Vulindlela Clinical Research Site ( Site 0029) - Pietermaritzburg, KwaZulu-Natal, South Africa
- Africa Health Research Institute (AHRI) - Mtubatuba ( Site 0049) - Somkhele - Mtubatuba, KwaZulu-Natal, South Africa
- SA Medical Research Council - Verulam Clinical Research Site ( Site 0036) - Verulam, KwaZulu-Natal, South Africa
- MU-JHU Research Collaboration - Mityana ( Site 0061) - Mityana, District, Mityana, Uganda
- UVRI Clinical Research Program Initiative Ltd (UVRI CRP) ( Site 0067) - Entebbe, Wakiso, Uganda
- Desmond Tutu Health Foundation. Philippi Village ( Site 0024) - Cape Town, Western Cape, South Africa
- DTHF Masiphumelele Clinical Research Site ( Site 0023) - Cape Town, Western Cape, South Africa
- Vuka Research Clinic ( Site 0025) - Khayelitsha, Western Cape, South Africa