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Oral ISL QM as PrEP in Cisgender Women at High Risk for HIV-1 Infection (MK-8591-022)
Oral ISL QM as PrEP in Cisgender Women at High Risk for HIV-1 Infection (MK-8591-022)

NCT04644029

TerminatedPhase 3

Sponsor: Merck Sharp & Dohme LLC

Conditions: HIV-I, Human Immunodeficiency Virus Type 1, Prophylaxis

Interventions: Islatravir, Placebo to FTC/TDF, FTC/TDF, Placebo to ISL

Countries: United States, South Africa, Uganda

This study will evaluate whether oral islatravir (ISL) is effective in preventing Human Immunodeficiency Virus Type 1 (HIV-1) infection in women at high-risk for HIV-1 infection. The study will compare oral ISL taken once a month with standard-of-care medication for prevention of HIV-1 infection, emtricitabine/tenofovir disoproxil (FTC/TDF), taken once per day. The primary hypothesis is that oral ISL is more effective than FTC/TDF at reducing the incidence rate per year of confirmed HIV-1 infections.

Eligibility overview

Sex: FEMALE

Age: 16 Years to 45 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Confirmed HIV-uninfected based on negative HIV-1/HIV-2 test results before randomization.
* Sexually active (vaginal and/or anal sex) with a male sexual partner in the 30 days prior to screening.
* High risk for HIV-1 infection.
* Not pregnant or breastfeeding, and one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or is a WOCBP and is using an acceptable contraceptive method during the intervention period and for at least 42 days after the last dose.
* A WOCBP must have a negative pregnancy test within 24 hours prior to the first dose of study intervention.

Exclusion Criteria:

* Hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator.
* Findings of chronic hepatitis B virus (HBV) infection or past HBV.
* Current or chronic history of liver disease.
* History of malignancy within 5 years of screening except for adequately-treated basal cell or squamous cell skin cancer, or in situ cervical cancer.
* Past or current use of cabotegravir, lenacapavir, or any other long-acting HIV prevention product.
* Currently participating in or has participated in an interventional clinical study with an investigational compound or device, within 30 days prior to Day 1.
* Expecting to conceive or donate eggs at any time during the study.
Locations (24)
  • Birmingham, Alabama, United States
  • Washington D.C., District of Columbia, United States
  • Miami, Florida, United States
  • Orlando, Florida, United States
  • Atlanta, Georgia, United States
  • Jackson, Mississippi, United States
  • Kansas City, Missouri, United States
  • Newark, New Jersey, United States
  • The Bronx, New York, United States
  • Chapel Hill, North Carolina, United States
  • Columbia, South Carolina, United States
  • Dallas, Texas, United States
  • Morgantown, West Virginia, United States
  • Johannesburg, Gauteng, South Africa
  • Johannesburg, Gauteng, South Africa
  • Johannesburg, Gauteng, South Africa
  • Pretoria, Gauteng, South Africa
  • Chatsworth, KwaZulu-Natal, South Africa
  • Durban, KwaZulu-Natal, South Africa
  • Ladysmith, KwaZulu-Natal, South Africa
  • Brits, North West, South Africa
  • Klerksdorp, North West, South Africa
  • Rustenburg, North West, South Africa
  • Kampala, Uganda