Safety and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative Adults
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|ClinicalTrials.gov Identifier: NCT03239483|
Recruitment Status : Recruiting
First Posted : August 4, 2017
Last Update Posted : December 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Dapivirine gel Drug: Placebo gel||Phase 1|
This study will evaluate the safety and pharmacokinetics (PK) of dapivirine gel (0.05%) administered rectally to HIV-1 seronegative adults.
Participants will be randomized to receive a single dose of either rectally administered dapivirine gel (0.05%) or placebo gel at study entry (Day 0). Following a minimum 2-week washout period, participants or study staff will administer daily rectal doses of the assigned gel for 7 consecutive days under direct observation in the clinic.
Participants will be in the study for approximately 40 days, and they will attend 16 study visits. Study visits may include behavioral assessments, physical examinations, blood and urine collection, and pelvic and anorectal sample collection. Some visits will include intensive PK sampling. Study staff will contact participants 1 week after Visit 16 for follow-up safety monitoring.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||27 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 :||October 26, 2017|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2018|
Experimental: Dapivirine gel
Participants will receive a single dose of dapivirine gel rectally, followed by 7 daily doses of dapivirine gel to be administered under direct observation in the clinic.
Drug: Dapivirine gel
Dapivirine gel (0.05%); administered rectally
Placebo Comparator: Placebo gel
Participants will receive a single dose of placebo gel rectally, followed by 7 daily doses of placebo gel to be administered under direct observation in the clinic.
Drug: Placebo gel
Universal HEC placebo gel; administered rectally
- Frequency of Grade 2 or higher adverse events (AEs) [ Time Frame: Measured through participants' last study visit at approximately Day 40 ]As defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 and/or Addenda 1, 2 and 3 (Female Genital [Dated November 2007], Male Genital [Dated November 2007] and Rectal [Clarification Dated May 2012] Grading Tables for Use in Microbicide Studies)
- Measurement of dapivirine concentrations in plasma [ Time Frame: Measured through participants' last study visit at approximately Day 40 ]As assessed by pharmacokinetic sampling and analysis
- Measurement of dapivirine concentrations in rectal fluid [ Time Frame: Measured through participants' last study visit at approximately Day 40 ]As assessed by pharmacokinetic sampling and analysis
- Measurement of dapivirine concentrations in rectal mucosal tissue homogenates [ Time Frame: Measured through participants' last study visit at approximately Day 40 ]As assessed by pharmacokinetic sampling and analysis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03239483
|United States, Alabama|
|Birmingham, Alabama, United States, 35294|
|Contact: Pam Cunningham, R.N., B.S.N., M.P.H. 205-975-2841 firstname.lastname@example.org|
|United States, Pennsylvania|
|University of Pittsburgh CRS||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Patricia Peters, R.Ph. 412-383-1434 email@example.com|
|Silom Community Clinic CRS||Recruiting|
|Nonthaburi, Bangkok, Thailand, 11000|
|Contact: Chaiwat Ungsedhapand, M.D. 66-26-446290 firstname.lastname@example.org|
|Study Chair:||Ross D. Cranston, MD, FRCP||Fundació Lluita Contra la Sida, Hospital Universitari Germans Trias I Pujol|