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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
MTN-026/IPM 038 will use the HTI pre-filled applicator, the same applicator that has been utilized in other rectal studies.
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Safety To characterize the systemic and compartmental pharmacokinetics of dapivirine gel following rectal application.
To evaluate the safety of dapivirine gel formulation when applied rectally.
Time frame: 9-12 months
Acceptability
To identify product attributes considered likely to challenge and facilitate future sustained use of rectally applied dapivirine gel.
Time frame: 9-12 months
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