A Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Radiopaque Matrix MK-8591 Implant in Participants at Low-Risk for HIV-1 Infection
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Percentage of participants withdrawing from study treatment due to adverse event (AE)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of an islatravir (ISL)-eluting implant. Participants will receive an implant placed in the upper arm for approximately 52 weeks with 8 weeks of follow-up in the Base Study. A subset of participants will also receive a second implant for an additional 12 weeks before 8 weeks of follow-up in the Substudy.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is in good health
- •Is confirmed human immunodeficiency virus (HIV)-uninfected
- •Is at low risk of HIV infection
- •For males, uses contraception in accordance with local regulations regarding contraception use for those participating in clinical trials
- •For females, is not pregnant or breastfeeding and one of the following applies:
- •Is not a participant of childbearing potential (POCBP)
- •Is a POCBP and uses an acceptable contraception method or is abstinent
排除标准
- •Has an active diagnosis of hepatitis (B or C) due to any cause
- •Has a history of malignancy ≤5 years before signing informed consent
- •Has a history or current evidence of any condition that might confound study results or interfere with study participation
- •Has a history of keloid in upper arm or presence of tattoo, scar, or other physical finding that could interfere with implant placement (the contralateral arm may be used if the findings are limited to 1 arm)
- •Is taking or is expected to take immunosuppressants during the study
研究组 & 干预措施
Islatravir 57 mg
Participants receive an ISL 57 mg implant for approximately 52 weeks. A subset of participants will receive a second implant for 12 weeks after removal of the first implant.
干预措施: Islatravir (Drug)
Islatravir 47 mg
Participants receive an ISL 47 mg implant for approximately 52 weeks. A subset of participants will receive a second implant for 12 weeks after removal of the first implant.
干预措施: Islatravir (Drug)
Islatravir 52 mg
Participants receive an ISL 52 mg implant for approximately 52 weeks. A subset of participants will receive a second implant for 12 weeks after removal of the first implant.
干预措施: Islatravir (Drug)
Placebo
Participants receive a placebo implant for approximately 52 weeks. A subset of participants will receive a second implant for 12 weeks after removal of the first implant.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of participants withdrawing from study treatment due to adverse event (AE)
时间窗: Up to 52 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.
Percentage of participants with ≥1 adverse events (AEs)
时间窗: Up to 60 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
- Plasma concentration of islatravir (ISL) 12 weeks after placement of an ISL-eluting implant (ISL C12weeks)(Week 12)
- Plasma concentration of islatravir (ISL) 52 weeks after placement of an ISL-eluting implant (ISL C52weeks)(Week 52)