Dapivirine Gel Rectal Safety and PK Study

Sponsor

International Partnership for Microbicides, Inc. (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT03044379

Collaborator

(none)

Enrollment

Location

Arms

25.1

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Dapivirine Gel Rectal Safety and PK Study

Condition or Disease	Intervention/Treatment	Phase
HIV 1 Infection	Drug: Dapivirine gel (0.05%) Other: Universal HEC placebo gel	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Other

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

Actual Study Start Date :

Sep 29, 2015

Anticipated Primary Completion Date :

Sep 1, 2017

Anticipated Study Completion Date :

Nov 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

International Partnership for Microbicides, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

International Partnership for Microbicides, Inc.

ClinicalTrials.gov Identifier:

NCT03044379

Other Study ID Numbers:

MTN-026/ IPM 038

First Posted:

Feb 7, 2017

Last Update Posted:

Feb 8, 2017

Last Verified:

Oct 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Dapivirine

Study Results

No Results Posted as of Feb 8, 2017