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IPM 042

Status
Completed
Phase
I
Objective
IPM 042 is a double-blinded Phase I trial that will determine the safety and tolerability of three doses of the DS003 vaginal tablet. This is the first time that DS003 is being studied in humans following the completion of preclinical safety assessments. Thirty-six healthy women volunteers in Belgium will be assigned to study groups in three stages. 
 
 
Last updated May 17, 2021
 
All women participating in the study will receive testing and counseling to reduce their risk of acquiring HIV and other STIs, including the provision of condoms, as well as contraception adherence counseling and other health services. The trial is expected to be completed in late 2016.
Prevention Option(s)
Microbicides
Study Design
Double-blind
Arms and Assigned Interventions
Description
The first group of 12 volunteers will be randomly assigned to use either a 1 mg DS003 or placebo tablet. For every three women who receive a DS003 tablet, one receives a placebo tablet.
Mode of Delivery
Tablet
Products
DS003
Description
Once researchers deem that the safety of 1mg DS003 tablet dose is satisfactory, the next group of 12 volunteers will be randomly assigned to receive either a 3 mg DS003 or placebo tablet. For every three women who receive a DS003 tablet, one receives a placebo tablet.
Mode of Delivery
Tablet
Products
DS003
Description
Once safety of the 10mg DS003 dose is deemed satisfactory, the third group of 12 volunteers will be randomly assigned to either a 10 mg DS003 or placebo tablet. For every three women who receive a DS003 tablet, one receives a placebo tablet.
Mode of Delivery
Tablet
Products
DS003
Trial Sponsors
IPM; USAID
November 2015
August 2016
Enrollment
36
18
Years
45
Years
Population
Women
Sites

Site(s) - Belgium

Belgium