A Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral MK-8527 Once Monthly in Participants at Low-Risk for HIV-1 Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 352
- 试验地点
- 30
- 主要终点
- Number of Participants With ≥1 Adverse Event (AE)
研究概览
简要总结
This double-blind, placebo-controlled study was designed to assess the safety, tolerability, and pharmacokinetics of oral MK-8527 taken once monthly (QM) in participants at low risk for human immunodeficiency virus Type 1 (HIV-1) infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test result before randomization
- •Has low-risk of HIV infection
- •Females: is not pregnant or breastfeeding and is either not a participant of childbearing potential (POCBP) OR is a POCBP and uses an acceptable contraception or is abstinent from penile-vaginal intercourse
排除标准
- •Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
- •Has an active diagnosis of hepatitis due to any cause, including active hepatitis B (HBV) infection (defined as HBsAg-positive) or hepatitis C virus (HCV) infection (defined as detectable HCV ribonucleic acid [RNA])
- •Prior use of MK-8527 or islatravir (MK-8591)
研究组 & 干预措施
MK-8527 Low Dose QM
Participants receive oral MK-8527 low dose QM for 6 months, followed by an 8-week blinded safety follow-up period.
干预措施: MK-8527 (Drug)
MK-8527 Medium Dose QM
Participants receive oral MK-8527 medium dose QM for 6 months, followed by an 8-week blinded safety follow-up period.
干预措施: MK-8527 (Drug)
MK-8527 High Dose QM
Participants receive oral MK-8527 high dose QM for 6 months, followed by an 8-week blinded safety follow-up period.
干预措施: MK-8527 (Drug)
Placebo to MK-8527
Participants receive oral placebo matched to MK-8527 QM for 6 months, followed by an 8-week blinded safety follow-up period.
干预措施: Placebo to MK-8527 (Drug)
结局指标
主要结局
Number of Participants With ≥1 Adverse Event (AE)
时间窗: Up to ~28 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Number of Participants Discontinuing Study Therapy Due to Adverse Event (AE)
时间窗: Up to ~20 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
次要结局
- Area Under the Plasma Concentration-Time Curve From Dosing to Last Measurable Concentration (AUC0-last) of MK-8527(Day 1: predose and 0.5, 4, and 24 hours postdose. Week 20: 0.5, 4, and 24 hours postdose)
- Maximum Plasma Concentration (Cmax) of MK-8527(Day 1: predose and 0.5, 4, and 24 hours postdose. Week 20: 0.5, 4, and 24 hours postdose)