IPM 032 (DREAM)

Status:Completed
Phase:Open Label
Principal Investigator(s):
Objective:DREAM (Dapivirine Ring Access and Monitoring), or IPM 032, is a follow-on Open-Label Trial to Assess Continued Safety of and Adherence to the Dapivirine (25mg) Vaginal Ring-004 in Healthy, HIV-Negative Women Results summary: Although efficacy estimation is limited by the absence of a placebo group, the observed low HIV-1 incidence and improved adherence observed in DREAM support the hypothesis that increased efficacy due to improved adherence occurs when women know the demonstrated safety and efficacy of the DVR. The feasibility of a visit schedule of once every 3 months was shown, indicating that the DVR can be used in a real-world situation and in usual clinical practice IPM study page Last updated October 20, 2022
Prevention Option(s):Microbicides
Study Design:Open label
Arms and Assigned Interventions
DescriptionEach participant will engage in the screening process for up to 45 days prior to enrollment and will use the monthly Dapivirine Vaginal Ring for a period of up to 12 months.
Mode of DeliveryRing
ARMsExperimental
Results: Safety, adherence, and HIV-1 seroconversion among women using the dapivirine vaginal ring
Official Code: NCT02862171
Related Publications:
HIV INCIDENCE AND ADHERENCE IN DREAM: AN OPEN-LABEL TRIAL OF DAPIVIRINE VAGINAL RING
HIV-1 Incidence, Adherence to Ring Use and Safety in an Open-label Trial of Dapivirine Vaginal Ring
Trial Sponsors: Denmark Ministry of Foreign Affairs, Dutch MFA, Flanders MFA, Irish Aid, PEPFAR, UK FCDO, USAID
Start Date
End Date
July 13, 2016
January 10, 2019
Enrollment:850
Age range: 18 Years ↔ 40 Years
Population:Cisgender Women