Dapivirine Gel Rectal Safety and PK Study

A Randomized, Double Blind, Placebo-Controlled, Phase 1 Safety and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative Adults

Dapivirine Gel Rectal Safety and PK Study

A Randomized, Double Blind, Placebo-Controlled Phase 1 Safety and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative Adults

Inclusion Criteria:

• 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

Exclusion Criteria: 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