To Assess Continued Safety of and Adherence to the Dapivirine (25 mg) Vaginal Ring-004 in Healthy, HIV-negative Women
Condition: HIV Prevention
Study type: Interventional
Phase: Phase 3

Summary: 
      A follow-on, open label trial to assess continued safety of and adherence to the
      Dapivirine(25mg) vaginal ring-004 in healthy, HIV-negative women
    

Detailed description: 
      Phase IIIb, multicenter follow-on open-label trial to evaluate the continued adherence to and
      safety of the DVR, inserted at monthly intervals by healthy, HIV negative women who had
      participated in the IPM 027 Phase III DVR trial. All women who participated in IPM 027 (NCT
      01539226) and were HIV-negative at screening for IPM 032, were eligible.

      Participants who provided written informed consent at screening were invited to undergo
      screening assessments for the trial. The Enrollment Visit had to occur within 45 days after
      the Screening Visit. Note: In the event that participation in IPM 027 was stopped prematurely
      and IPM 032 was activated at the RC, the IPM 027 Last Product Use Visit (LPUV) and the IPM
      032 Screening and Enrollment Visits could be combined for participants who were eligible to
      enroll in IPM 032.

      All participants received the DVR containing 25 mg dapivirine at the Enrollment Visit, and
      attended a visit at the RC, 1 month after enrollment. Following this visit, a participant
      could continue on a 3 monthly visit schedule, at the Investigator's discretion. Monthly
      visits could, however, be extended up to the first 3 months of participation. From then on,
      all participants needed to switch to a 3-monthly schedule. Once the 3-monthly trial visit
      schedule commenced, three rings were dispensed at each visit. One ring was self-inserted at
      the RC and two additional rings were dispensed for the participant to take home, or
      dispensing took place as arranged with the participant.

      The protocol made provision for at least 12 months of DVR use (with the LPUV scheduled at
      Month 12), which could also have been extended. Participants could continue with ring use
      past Month 12 and the RCs could continue scheduling the 3-monthly visits as per the
      participant visit schedule. Exit Visits of participants who completed 12 months or more on
      the trial commenced in October 2017 and ended in January 2019. Participants who were still
      enrolled in the trial in October 2017 and those who had been enrolled at a later stage in the
      trial were scheduled to attend the Month 12 Visit, irrespective of their visit schedule
      assignments. Exit Visits were then scheduled as per protocol, ie, 1 to 2 months after the
      Month 12 Visit. Exit Visits were optional for participants who discontinued early from the
      trial.

      Adherence assessments included analysis of dapivirine residual levels in returned used rings,
      correlation analysis of dapivirine residual levels with visual inspection of used rings, and
      self-reported acceptability and adherence.

      The HIV-1 incidence and the occurrence of HIV-1 drug resistance were assessed using HIV rapid
      testing and genotyping, respectively.

      Social and behavioral parameters were assessed qualitatively and quantitatively. Quantitative
      assessments included evaluation of the feasibility of 3-monthly follow-up visits and
      evaluation of the proportion of participants undergoing unscheduled HIV rapid tests (ie, in
      between the scheduled 3 monthly follow-up visits).

      Safety assessments included adverse event (AE) reporting, safety laboratory assessments,
      pregnancy testing, physical examination, vital sign assessments, pelvic examination, sexually
      transmitted infection (STI) tests, cervical cytology, and assessments of social harms.

      Throughout the trial, all participants received pre- and post-test HIV counseling, HIV/STI
      risk reduction counseling, and contraceptive, condom and vaginal ring adherence counseling.
    

Intervention name(s): Dapivirine Vaginal Ring-004
Intervention type(s): Drug
Intervention description(s): To assess the safety profile of the 25 mg Dapivirine Vaginal Ring-004, when inserted at monthly intervals, in an open-label trial
Other intervention name(s): TMC-120
Intervention MeSH terms: Dapivirine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention