Dapivirine Gel Rectal Safety and PK Study

International Partnership for Microbicides (IPM)

Status and phase: Withdrawn; Phase 1

Conditions: HIV 1 Infection

Treatments: Other: Universal HEC placebo gel; Drug: Dapivirine gel (0.05%)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03044379

MTN-026/ IPM 038

Details and patient eligibility

About

Dapivirine Gel Rectal Safety and PK Study

Full 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

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Dapivirine Gel

Active Comparator group

Description:

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.

Treatment:

Drug: Dapivirine gel (0.05%)

Placebo Gel HEC

Placebo Comparator group

Description:

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.

Treatment:

Other: Universal HEC placebo gel