A Phase 3, Randomized, Active-Controlled, Double-blind Clinical Study to Evaluate the Efficacy and Safety of Oral Islatravir Once-Monthly as Preexposure Prophylaxis in Cisgender Women at High Risk for HIV-1 Infection - Oral ISL QM as PrEP in Cisgender Women at High Risk for HIV-1 Infection

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 个研究点开始时间: 2021年10月25日最近更新: 2024年5月13日

适应症

试验速览

暂无简介。

•- 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.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 100
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 4400
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- 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

发起方