Dapivirine Gel Rectal Safety and PK Study

NCT03044379 | Withdrawn Phase 1

• 1 other identifier: MTN-026/ IPM 038
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Dapivirine Gel Rectal Safety and PK Study

Conditions

HIV 1 Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Acceptability

  9-12 months

Study Arms (2)

Dapivirine Gel

ACTIVE COMPARATOR

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%)

Placebo Gel HEC

PLACEBO COMPARATOR

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

Interventions

Dapivirine gel (0.05%) DRUG

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

Dapivirine Gel

Universal HEC placebo gel OTHER

Placebo Gel HEC

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• International Partnership for Microbicides, Inc.: lead

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2016
• First Posted: February 7, 2017
• Study Start: September 29, 2015
• Primary Completion: September 1, 2017
• Study Completion: November 1, 2017
• Last Updated: February 8, 2017

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)