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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 4,580
- 试验地点
- 53
- 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
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
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 30 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
FTC/TDF + Placebo to MK-8527
Participants will receive 200 mg FTC/245 mg TDF QD and placebo matched to MK-8527 QM for up to approximately 2 years. Participants will then receive open-label 200 mg FTC/245 mg TDF QD for an additional 28 days.
干预措施: Emtricitabine/tenofovir disoproxil (FTC/TDF) (Drug)
MK-8527 + Placebo to FTC/TDF
Participants will receive 11 mg MK-8527 once monthly (QM) and placebo matched to Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) once daily (QD) for up to approximately 2 years. Participants will then receive open-label 200 mg FTC/245 mg TDF QD for an additional 28 days.
干预措施: Placebo matched to FTC/TDF (Drug)
MK-8527 + Placebo to FTC/TDF
Participants will receive 11 mg MK-8527 once monthly (QM) and placebo matched to Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) once daily (QD) for up to approximately 2 years. Participants will then receive open-label 200 mg FTC/245 mg TDF QD for an additional 28 days.
干预措施: MK-8527 (Drug)
FTC/TDF + Placebo to MK-8527
Participants will receive 200 mg FTC/245 mg TDF QD and placebo matched to MK-8527 QM for up to approximately 2 years. Participants will then receive open-label 200 mg FTC/245 mg TDF QD for an additional 28 days.
干预措施: Placebo matched to MK-8527 (Drug)
结局指标
主要结局
Number of Participants with Adjudicated Human Immunodeficiency Virus Type 1 (HIV-1) Infection
时间窗: Up to ~2 years
The number of participants with adjudicated HIV-1 infection will be presented.
Number of Participants who Experience At Least One Adverse Event (AE)
时间窗: Up to ~2 years
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. The number of participants that experienced AEs will be presented.
Number of Participants who Discontinue Study Intervention Due to an AE
时间窗: Up to ~2 years
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. The number of participants that discontinued study intervention due to an AE will be presented.
次要结局
未报告次要终点