IPM 054

Status:Ongoing
Phase:I
Principal Investigator(s):Anél Dr Pretorius
Objective:A Phase I, Open-Label, Randomized, Crossover Trial to Investigate the Relative Bioavailability of the 25 mg Dapivirine Vaginal Ring-004 Inserted Every 30 Days and 100 mg DPV Ring-008 Inserted for 90 Days in Healthy Female Participants IPM 054 is a Phase I, open-label, randomized, crossover trial to determine the relative bioavailability in plasma and vaginal fluid of two formulations of the dapivirine vaginal ring in HIV-negative women. The trial will compare the dapivirine concentrations achieved in plasma and vaginal fluid over all timepoints for each 90-day use period in a two-period, two-sequence, crossover design. Participants will be randomized to one of two treatment sequences (AB or BA). During two consecutive 90-day treatment periods, the participants will receive each of the following treatments according to their assigned treatment sequence. The treatment periods will be separated by a 28-day washout period. Last updated September 23, 2022
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