To assess the safety of dapivirine (25 mg) administered via a silicone vaginal ring in HIV-uninfected adolescent females, when inserted once every 4 weeks during 24-week of study product use.
MTN-023/IPM 030 is a Phase 2a, two-arm, placebo-controlled, double-blinded, multi-site, randomized trial of dapivirine vaginal ring (VR) versus placebo VR. The clinical trial is designed to assess the safety of dapivirine (25 mg) administered via a silicone vaginal ring (primary objective) and evaluate the acceptability of the dapivirine or placebo VR in sexually experienced, HIV-uninfected adolescent females, when inserted once every 4 weeks during 24-weeks of study product use. Approximately 96 participants will be randomized in a 3:1 ratio to receive either a silicone elastomer vaginal ring containing 25 mg of dapivirine or a placebo VR. The ring will be replaced every 4 weeks during the 24 week study product use period. Use of a VR to provide sustained delivery of microbicides is a novel investigational method for prevention of heterosexual transmission of HIV in women. This drug delivery method may circumvent potential difficulties related to adherence to daily or coitally-dependent uses of microbicide regimens.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
96
intravaginal ring silicone elastomer intravaginal ring containing no drug product
intravaginal ring silicone elastomer intravaginal ring containing 25 mg dapivirine
Alabama CRS 84519th street south, BBRB 203A
Birmingham, Alabama, United States
The university of Colorado, 13123 E. 16th Ave., Box 025
Aurora, Colorado, United States
The University of Colorado; 13123 E. 16th Ave., Box 025
The Safety of Dapivirine (25 mg) Administered Via a Silicone Vaginal Ring in HIV-uninfected Adolescent Females, When Inserted Once Every 4 Weeks During 24 Weeks of Study Product Use
Grade 2 AEs as defined by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December 2004 (Clarification dated August 2009), Addendum 1 (Female Genital Grading Table for Use in Microbicide Studies) judged to be related to IP. Grade 3 or higher AEs as defined by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December 2004 (Clarification dated August 2009).
Time frame: 6 months
The Acceptability of the Study VR (Dapivirine or Placebo) in HIV Uninfected Adolescent Females, When Inserted Once Every 4 Weeks for a 24 Week Period
Participant's self-report on multiple components of acceptability via attitudinal questions (discreetness, likes and dislikes concerning the ring, attitude toward product characteristics, comfort and ease of use, partner reactions, and effect on sex) in categorical scales
Time frame: 6 months
Adherence to the Study VR (Dapivirine or Placebo) in HIV Uninfected Adolescent Females, When Inserted Once Every 4 Weeks for a 24 Week Period
Frequency of ring removals and expulsions based on the participant's self-report of ring use at monthly clinic visits according to the Ring Adherence CRF.
Time frame: 6 months
The Systemic Dapivirine Exposure
Dapivirine plasma concentrations measured at weeks 2, 4, 12 and 24.
Time frame: 6 months
Local Dapivirine Exposure
Vaginal fluid dapivirine concentrations.
Time frame: 6 months
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Aurora, Colorado, United States
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Boston, Massachusetts, United States
The Fenway Institute; 1340 Boylston Street
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The Bronx, New York, United States
Montefiore Medical Center; 3514 Wayne Ave
The Bronx, New York, United States
University of Pittsburgh CRS, 3601 fifth Ave, Room 737
Pittsburgh, Pennsylvania, United States
University of Pittsburgh CRS, 3601 Fifth Avenue, Room 737; Falk Medical Building,
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