Dapivirine Gel Rectal Safety and PK Study

NCT ID: NCT03044379

Last Updated: 2017-02-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-29
• Study Completion Date: 2017-11-30

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

Conditions

HIV 1 Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Dapivirine gel (0.05%)

Intervention Type: DRUG

MTN-026/IPM 038 will use the HTI pre-filled applicator, the same applicator that has been utilized in other rectal studies.

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.

Group Type: PLACEBO_COMPARATOR

Universal HEC placebo gel

Intervention Type: OTHER

Interventions

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.

Intervention Type: DRUG

Universal HEC placebo gel

Intervention Type: OTHER

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

International Partnership for Microbicides, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

MTN-026/ IPM 038

Identifier Type: -

Identifier Source: org_study_id