IPM 042
Status:Completed
Phase:I
Principal Investigator(s):
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
DescriptionThe 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 DeliveryTablet
ARMs
DescriptionOnce 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 DeliveryTablet
ARMs
DescriptionOnce 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 DeliveryTablet
ARMs
Official Code:
NCT02877979
Trial Sponsors:
IPM, USAID
Start Date
End Date
November 3, 2015
August 14, 2016
Enrollment:36
Age range:
18 Years ↔
45 Years
Population:Cisgender Women