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RECRUITINGPhase 3INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: The main inclusion criteria include but are not limited to the following: - Is confirmed Human weakened immune system 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 Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

MK-8527

Oral tablet

DRUG

Emtricitabine/tenofovir disoproxil (FTC/TDF)

Oral tablet

DRUG

Placebo matched to MK-8527

Placebo oral tablet matched to MK-8527

DRUG

Placebo matched to FTC/TDF

Placebo oral tablet matched to FTC/TDF

Locations (20)

UW - KNH; Rachuonyo County Hospital ( Site 0006)
Homabay County, Homa Bay County, Kenya
Partners in Health and Research Development (PHRD) ( Site 0002)
Thika, Kiambu County, Kenya
KEMRI-CMR-RCTP ( Site 0003)
Nairobi, Kisumu County, Kenya
Kargeno Research & Policy Hub ( Site 0007)
Kisumu, Kenya
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
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