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

Dapivirine Gel Rectal Safety and PK Study

Study Overview

• Status: Withdrawn
• Conditions: HIV 1 Infection
• Intervention / Treatment: Drug: Dapivirine gel (0.05%); Other: Universal HEC placebo gel

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 Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	9-12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: International Partnership for Microbicides, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2015
• Primary Completion (Anticipated): September 1, 2017
• Study Completion (Anticipated): November 1, 2017

Study Registration Dates

• First Submitted: September 6, 2016
• First Submitted That Met QC Criteria: February 2, 2017
• First Posted (Estimate): February 7, 2017

Study Record Updates

• Last Update Posted (Estimate): February 8, 2017
• Last Update Submitted That Met QC Criteria: February 6, 2017
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; Dapivirine
• Other Study ID Numbers: MTN-026/ IPM 038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No