Dapivirine Gel Rectal Safety and PK Study

NCT03044379 — Phase 1, Withdrawn, International Partnership for Microbicides, Inc.

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A Randomized, Double Blind, Placebo-Controlled, Phase 1 Safety and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative Adults

Registry	NCT03044379
Status	Withdrawn - Current program is on hold, not for safety reason
Phase	Phase 1
Study type	Interventional; randomized, parallel, masking: double, other
Sponsor	International Partnership for Microbicides, Inc. (Industry)
Conditions	HIV 1 Infection
Interventions	Dapivirine gel (0.05%), Universal HEC placebo gel (Drug, other)
Dates	start 2015-09-29, primary completion 2017-09-01 (estimated), completion 2017-11-01 (estimated), first posted 2017-02-07, last updated 2017-02-08
Locations	1 site in United States

-Summary

Dapivirine Gel Rectal Safety and PK Study

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+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

+Arms and interventions

Arm	Type	Interventions	Description
Dapivirine Gel	Active comparator	Drug: Dapivirine gel (0.05%)	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.
Placebo Gel HEC	Placebo comparator	Other: Universal HEC placebo gel	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.

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.
Universal HEC placebo gel (Other)

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 45 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
University of Pittsburgh Medical Center	Pittsburgh, Pennsylvania	United States