Dapivirine Gel Rectal Safety and PK Study

Withdrawn before enrolling · Phase 1 · Has a placebo group

Conditions studied: HIV 1 Infection

In brief

Dapivirine Gel Rectal Safety and PK Study

Key facts

Study ID

NCT03044379

Run by

International Partnership for Microbicides, Inc.

People needed

0

Starts

2015-09-29

Expected to finish

2017-11-01

Last updated by the study team

2017-02-08

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

Where it is running

• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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