Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
International Partnership for Microbicides, Inc.
A Randomized, Double Blind, Placebo-Controlled Phase 1 Safety and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative Adults
Age
18–45
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Dapivirine Gel Rectal Safety and PK Study
