A Randomized, Double Blind, Placebo-Controlled, Phase 1 Safety and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative Adults
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Safety To characterize the systemic and compartmental pharmacokinetics of dapivirine gel following rectal application.
研究概览
简要总结
Dapivirine Gel Rectal Safety and PK Study
详细描述
A Randomized, Double Blind, Placebo-Controlled Phase 1 Safety and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative Adults
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age of 18 - 45 years (inclusive), verified per site SOP
- •Able and willing to provide written informed consent
- •HIV-1/2 uninfected at Screening and Enrollment, per applicable algorithm in Appendix II and willing to receive HIV test results
- •Able and willing to provide adequate locator information, as defined in site SOP
- •Available to return for all study visits and willing to comply with study participation requirements
- •In general good health at Screening and Enrollment, as determined by the site IoR or designee
- •Per participant report, a history of consensual RAI at least once in the past calendar year
- •Willing to not take part in other research studies involving drugs, medical devices, genital products, or vaccines for the duration of study participation, including the time between Screening and Enrollment
排除标准
- •At Screening:
- •Hemoglobin Grade 1 or higher*
- •Platelet count Grade 1 or higher*
- •White blood count Grade 2 or higher*
- •Serum creatinine 1.3 the site laboratory upper limit of normal (ULN)
- •International normalized ratio (INR) 1.5 the site laboratory ULN
- •Aspartate aminotransferase (AST) or alanine transaminase (ALT) Grade 1 or higher*
- •Positive for hepatitis C antibody
- •Positive for hepatitis B surface antigen
- •History of inflammatory bowel disease by participant report
研究组 & 干预措施
Dapivirine Gel
Participants will be randomized to receive a single dose of dapivirine gel rectally, followed by 7 daily doses of the same product to be administered under direct observation in the clinic.
干预措施: Dapivirine gel (0.05%) (Drug)
Placebo Gel HEC
Participants will be randomized to receive the universal HEC placebo gel rectally, followed by 7 daily doses of the same product to be administered under direct observation in the clinic.
干预措施: Universal HEC placebo gel (Other)
结局指标
主要结局
Safety To characterize the systemic and compartmental pharmacokinetics of dapivirine gel following rectal application.
时间窗: 9-12 months
To evaluate the safety of dapivirine gel formulation when applied rectally.
次要结局
- Acceptability(9-12 months)