IPM 056 / CCN019B

Status:Ongoing
Phase:I/II
Principal Investigator(s):John Steytler
Objective:A Randomized, Double-Blind, Phase 1b Study in Healthy HIV-Negative Women to Evaluate the Pharmacokinetics, Safety, and Bleeding Patterns Associated With 90-Day Use of Core-Sheath Vaginal Rings Releasing Dapivirine and Levonorgestrel Last updated September 23, 2022
Prevention Option(s):MPTs, PrEP
Study Design:Double-blind, Randomized
Arms and Assigned Interventions
DescriptionArm Intervention/treatment Experimental: IPM Ring-105 Ring-105 (xx mg dapivirine + xxx mg levonorgestrel)
Mode of DeliveryRing
ARMsExperimental
DescriptionActive Comparator: IPM Ring-106. Ring-106 (xx mg dapivirine + xxx mg levonorgestrel)
Mode of DeliveryRing
ARMsActive Comparator
Official Code: NCT05041699
Trial Sponsors: IPM, NICHD, NIH
Start Date
End Date
June 1, 2022
September 23, 2023
Enrollment:40
Age range: 18 Years ↔ 45 Days
Population:Cisgender Women