Dapivirine Gel Rectal Safety and PK Study
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|ClinicalTrials.gov Identifier: NCT03044379|
Recruitment Status : Withdrawn (Current program is on hold, not for safety reason)
First Posted : February 7, 2017
Last Update Posted : February 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV 1 Infection||Drug: Dapivirine gel (0.05%) Other: Universal HEC placebo gel||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Double Blind, Placebo-Controlled, Phase 1 Safety and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative Adults|
|Actual Study Start Date :||September 29, 2015|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||November 2017|
Active Comparator: 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.
Drug: Dapivirine 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.
Placebo Comparator: 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.
Other: Universal HEC placebo gel
- Safety To characterize the systemic and compartmental pharmacokinetics of dapivirine gel following rectal application. [ Time Frame: 9-12 months ]To evaluate the safety of dapivirine gel formulation when applied rectally.
- Acceptability [ Time Frame: 9-12 months ]To identify product attributes considered likely to challenge and facilitate future sustained use of rectally applied dapivirine gel.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03044379
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|