Dapivirine Gel Rectal Safety and PK Study

Study Overview
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Brief Summary
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Dapivirine Gel Rectal Safety and PK Study

Detailed Description
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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

Official Title
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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

Conditions
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HIV 1 Infection

Intervention / Treatment
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* Drug: Dapivirine gel (0.05%)
* Other: Universal HEC placebo gel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dapivirine Gel<br>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%)<br>* MTN-026/IPM 038 will use the HTI pre-filled applicator, the same applicator that has been utilized in other rectal studies.<br>|
| Placebo Comparator: Placebo Gel HEC<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability | To identify product attributes considered likely to challenge and facilitate future sustained use of rectally applied dapivirine gel. | 9-12 months |