HIV 1 Infection
Conditions
Brief summary
Dapivirine Gel Rectal Safety and PK Study
Detailed description
A Randomized, Double Blind, Placebo-Controlled Phase 1 Safety and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative Adults
Interventions
DRUGDapivirine gel (0.05%)
MTN-026/IPM 038 will use the HTI pre-filled applicator, the same applicator that has been utilized in other rectal studies.
OTHERUniversal HEC placebo gel
Sponsors
International Partnership for Microbicides, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety To characterize the systemic and compartmental pharmacokinetics of dapivirine gel following rectal application. | 9-12 months | To evaluate the safety of dapivirine gel formulation when applied rectally. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability | 9-12 months | To identify product attributes considered likely to challenge and facilitate future sustained use of rectally applied dapivirine gel. |
Countries
United States
Outcome results
None listed