Dapivirine Gel Rectal Safety and PK Study

Phase 1

Withdrawn

• Conditions: HIV 1 Infection
• Interventions: Drug: Dapivirine gel (0.05%); Other: Universal HEC placebo gel

• Registration Number: NCT03044379
• Lead Sponsor: International Partnership for Microbicides, Inc.

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

Study Timeline

• Study Start: 2015-09-29
• Study First Submitted: 2016-09-06
• Status Verified: 2016-10
• Study First Submitted QC: 2017-02-02
• Last Update Submitted: 2017-02-06
• Study First Posted: 2017-02-07
• Last Update Posted: 2017-02-08
• Primary Completion: 2017-09
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dapivirine Gel	Dapivirine gel (0.05%)	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.
Placebo Gel HEC	Universal HEC placebo gel	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Acceptability	9-12 months	To identify product attributes considered likely to challenge and facilitate future sustained use of rectally applied dapivirine gel.

Trial Locations

Locations (1)

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States