Dapivirine Gel Rectal Safety and PK Study

HIV 1 Infection Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03044379
• Other study ID #: MTN-026/ IPM 038
• Status: Withdrawn
• Phase: Phase 1
• First received: September 6, 2016
• Last updated: February 6, 2017
• Start date: September 29, 2015
• Est. completion date: November 2017

Study information

• Verified date: October 2016
• Source: International Partnership for Microbicides, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Dapivirine Gel Rectal Safety and PK Study

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV 1 Infection

Intervention

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.

Other:
• Universal HEC placebo gel

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
International Partnership for Microbicides, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Acceptability	To identify product attributes considered likely to challenge and facilitate future sustained use of rectally applied dapivirine gel.	9-12 months