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

NCT07071623

RecruitingPhase 3

Sponsor: Merck Sharp & Dohme LLC

Conditions: Human Immunodeficiency Virus (HIV), HIV Pre-Exposure Prophylaxis

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

Countries: Kenya, South Africa, Uganda

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

Eligibility overview

Sex: FEMALE

Age: 16 Years to 30 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (30)
  • Homabay County, Homa Bay County, Kenya
  • Thika, Kiambu County, Kenya
  • Nairobi, Kisumu County, Kenya
  • Kisumu, Kenya
  • East London, Eastern Cape, South Africa
  • Ndevana, Eastern Cape, South Africa
  • Bloemfontein, Free State, South Africa
  • Johannesburg, Gauteng, South Africa
  • Johannesburg, Gauteng, South Africa
  • Johnnesburg, Gauteng, South Africa
  • Pretoria, Gauteng, South Africa
  • Chatsworth, KwaZulu-Natal, South Africa
  • Durban, KwaZulu-Natal, South Africa
  • Durban, KwaZulu-Natal, South Africa
  • Durban, KwaZulu-Natal, South Africa
  • Durban, KwaZulu-Natal, South Africa
  • Edendale, KwaZulu-Natal, South Africa
  • Ladysmith, KwaZulu-Natal, South Africa
  • Phoenix, KwaZulu-Natal, South Africa
  • Pietermaritzburg, KwaZulu-Natal, South Africa
  • Somkhele - Mtubatuba, KwaZulu-Natal, South Africa
  • Verulam, KwaZulu-Natal, South Africa
  • Cape Town, Western Cape, South Africa
  • Cape Town, Western Cape, South Africa
  • Khayelitsha, Western Cape, South Africa
  • Entebbe, Central Region, Uganda
  • Kalangala District, Kalangala, Uganda
  • Mityana, District, Mityana, Uganda
  • Entebbe, Wakiso, Uganda
  • Kampala, Uganda