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IPM 035

Status
Completed
Phase
I
Objective

IPM 035 is a clinical trial designed to assess the effects of menses, and of tampon use during menses, on the local and systemic pharmacokinetics of the dapivirine ring when used by HIV-negative women over a period of 28 days.

*In data analysis as of August 2016*

 

Last updated May 15, 2021

Prevention Option(s)
Microbicides
Study Design
Randomized
Open label
Arms and Assigned Interventions
Description
In Cohort I, eligible participants will be randomly assigned to one of two treatment sequences (ABE or BAE). During two consecutive 28-day treatment periods (treatment periods 1 and 2), separated by a washout period of 28 days, the participants will receive each of the following treatments according to their assigned treatment sequence
Mode of Delivery
Ring
Products
Dapivirine Ring
ARMs
Experimental
Description
In Cohort II, eligible participants will be randomly assigned to one of two treatment sequences (CDE or DCE). During two consecutive 28-day treatment periods (treatment periods 1 and 2), separated by a washout period of 28 days, the participants will receive each of the following treatments according to their assigned treatment sequence
Mode of Delivery
Ring
Products
Dapivirine Ring
ARMs
Experimental
Trial Sponsors
IPM
January 2015
April 2016
Enrollment
16
18
Years
45
Years
Population
Women
Sites

SGS Life Sciences

Belgium