Email Updates

You are here

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

Study Design
Randomized
Open label
Arms and Assigned Interventions
Description
Active Comparator: 25 mg dapivirine ring 25 mg dapivirine vaginal ring (Ring-004) for 90 days (replaced every 30 days) (Treatment A), followed by the 100 mg dapivirine ring (Ring-008) used continuously for 90 days (Treatment B)
Mode of Delivery
Ring
Products
Dapivirine Ring
ARMs
Active Comparator
Description
Active Comparator: 100 mg dapivirine ring 100 mg dapivirine vaginal ring (Ring-008) used continuously for 90 days (Treatment B), followed by the 25 mg dapivirine ring (Ring-004) for 90 days (replaced every 30 days) (Treatment A)
Mode of Delivery
Ring
Products
Dapivirine Ring
ARMs
Active Comparator
Trial Sponsors
International Partnership for Microbicides, Inc.
August 2022
September 2023
Enrollment
110
18
Years
45
Years
Population
Women
Sites

FARMOVS

Bloemfontein
South Africa