IPM 020
Status:Completed
Phase:II, I
Principal Investigator(s):Dr Annalene Nel
Objective:IPM 020 is a double-blind, randomized, placebo-controlled Phase I/II expanded safety trial being conducted at 5 research centers in the United States among approximately 180 healthy, sexually active, HIV-negative women to assess the safety of Dapivirine Gel 4759, 0.05% 2.5g and Dapivirine Gel 4789, 0.05% 2.5g as compared to the HEC-based universal placebo.
Prevention Option(s):Microbicides
Study Design:Randomized
Arms and Assigned Interventions
Descriptiondapivirine gel 4789, 0.05%, 2.5g applied once daily
Mode of DeliveryGel
ARMsExperimental
Descriptiondapivirine gel 4759, 0.05%, 2.5g applied once daily
Mode of DeliveryGel
ARMsExperimental
Official Code:
NCT00799058
Trial Sponsors:
IPM
Start Date
End Date
June 1, 2009
April 1, 2011
Enrollment:180
Age range:
18 Years ↔
40 Years
Population:Cisgender Women