Participants will be randomized to one of three study vaginal rings (VRs) in a 1:1:1 ratio, 25 mg, 100 mg or 200 mg VRs.
Participants will be randomized to one of three study vaginal rings (VRs) in a 1:1:1 ratio, and those randomized to the 100 mg and 200 mg VRs will not be told their group assignment. Participants will insert one VR to be used continuously for 13 weeks (100 mg VR or 200 mg VR) or one VR (25 mg VR) to be replaced every 4 weeks for 8 weeks, then worn for an additional 5 weeks for a total of 13 weeks. Participants will continue follow-up for an additional one to three days after final VR removal.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
49
Vaginal Ring containing 25 mg dapivirine
Vaginal Ring containing 100 mg dapivirine
Vaginal Ring containing 200 mg dapivirine
University of Alabama at Birmingham
Birmingham, Alabama, United States
Bridge HIV CRS San Francisco Department of Public Health
San Francisco, California, United States
DPV concentration in plasma.
To compare the local and systemic pharmacokinetics (PK) of two extended duration DPV VRs (100 mg and 200 mg) when used continuously for 13 weeks to the current 25 mg DPV VR when replaced every 4 weeks for 8 weeks and then worn for an additional 5 weeks for a total of 13 weeks.
Time frame: 13 weeks
DPV concentration in cervicovaginal fluid
To compare the local and systemic pharmacokinetics (PK) of two extended duration DPV VRs (100 mg and 200 mg) when used continuously for 13 weeks to the current 25 mg DPV VR when replaced every 4 weeks for 8 weeks and then worn for an additional 5 weeks for a total of 13 weeks.
Time frame: 13 weeks
DPV concentration in cervical tissue
To compare the local and systemic pharmacokinetics (PK) of two extended duration DPV VRs (100 mg and 200 mg) when used continuously for 13 weeks to the current 25 mg DPV VR when replaced every 4 weeks for 8 weeks and then worn for an additional 5 weeks for a total of 13 weeks.
Time frame: 13 weeks
Safety comparison of the two extended duration DPV VRs (100 mg and 200 mg) to the current 25 mg DPV VR
* Proportions of participants with Grade 2 or higher genitourinary adverse events as defined by the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017, and/or Addendum 1 (Female Genital Grading Table for Use in Microbicide Studies \[Dated November 2007\]) * Proportions of participants with Grade 3 or higher adverse events as defined by the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017
Time frame: 13 weeks
Adherence
• Frequency of study VR removal/expulsions (voluntary and involuntary) and duration without VR in vagina (by self-report)
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Time frame: 13 weeks
Adherence
• VR use initiation and persistence (whether the VR is in place when participants come to the clinic for their study visits)
Time frame: 13 weeks
Acceptability
Degree to which study participants liked or disliked using the three DPV VRs (by self-report)
Time frame: 13 weeks