2025-520610-58-00招募中3 期
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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of Participants With Adjudicated Human Immunodeficiency Virus Type 1(HIV-1) Infection
研究概览
简要总结
- To evaluate the efficacy of MK-8527 qm compared to FTC/TDF qd for the prevention of HIV-1 infection as assessed by the incidence rate per year of adjudicated HIV-1 infections.
- To evaluate the safety and tolerability of MK-8527 qm compared to FTC/TDF qd.
入排标准
- 年龄范围
- 0 years 至 65+ years（18-64 Years, 0-17 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test results
- •Is a cisgender man, transgender woman (assigned male sex at birth), transgender man (assigned female sex at birth), or gender nonbinary person
- •Has had condomless receptive anal sex in the 12 months prior to screening (not including sex occurring in a mutually monogamous relationship) and has at least 1 of the following: receptive anal sex with 2 or more partners in the 3 months prior to screening (regardless of condom use), rectal or urethral gonorrhea or chlamydia or incident syphilis in the 6 months prior to screening, or any self-reported stimulant drug use with sex in the 3 months prior to screening
- •Is ≥16 years of age
- •Weighs ≥35 kg
排除标准
- •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 anal or cervical cancers
- •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
- •Is expecting to donate eggs at any time during the study
结局指标
主要结局
Number of Participants With Adjudicated Human Immunodeficiency Virus Type 1(HIV-1) Infection
Number of Participants With Adjudicated Human Immunodeficiency Virus Type 1(HIV-1) Infection
Number of Participants Who Experience At Least One Adverse Event (AE)
Number of Participants Who Experience At Least One Adverse Event (AE)
Number of Participants Who Discontinue Study Intervention Due to an AE
Number of Participants Who Discontinue Study Intervention Due to an AE
次要结局
未报告次要终点
研究者
Christopher Bruno
Scientific
Merck Sharp & Dohme LLC
研究点 (1)
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