An Expanded Safety Study of Dapivirine Gel 4759 in Africa
A Double-blind, Randomized, Placebo-Controlled Phase I/II Study to Evaluate the Safety and Acceptability of Dapivirine Gel 4759, 0.05%, 2.5g, a Vaginal Microbicide, Conducted Using Daily Monitored Adherence in Healthy, HIV-Negative Women.
Sponsor: International Partnership for Microbicides, Inc.
Listed as NCT00917891, this PHASE1/PHASE2 trial focuses on Acquired Immunodeficiency Syndrome and HIV Infections and remains completed. Sponsored by International Partnership for Microbicides, Inc., it has been updated 6 times since 2009, reflecting limited change activity. This study is part of the global effort to build evidence for infectious disease interventions.
Status Flow
Change History
6 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE1/PHASE2
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE1/PHASE2
Phase: PHASE1_PHASE2 → PHASE1/PHASE2
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Jan 2021 — Jul 2024 [monthly]
Completed PHASE1_PHASE2
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE1_PHASE2
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Feb 2017 — Jun 2018 [monthly]
Completed PHASE1_PHASE2
▶ Show 1 earlier version
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Jan 2017 — Feb 2017 [monthly]
Completed PHASE1_PHASE2
First recorded
Nov 2009
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- International Partnership for Microbicides, Inc.
For direct contact, visit the study record on ClinicalTrials.gov .