A Safety Study of Two Dapivirine (TMC120) Vaginal Gels in the United States
A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE I/II TRIAL TO EVALUATE THE SAFETY OF DAPIVIRINE GEL 4759, 0.05% 2.5g AND DAPIVIRINE GEL 4789, 0.05% 2.5g FORMULATIONS AS COMPARED TO THE VAGINAL HEC-BASED UNIVERSAL PLACEBO GEL, 2.5g IN HEALTHY HIV-NEGATIVE WOMEN
Sponsor: International Partnership for Microbicides, Inc.
Listed as NCT00799058, this PHASE1/PHASE2 trial focuses on HIV-1 Infections and remains completed. Sponsored by International Partnership for Microbicides, Inc., it has been updated 12 times since 2009, reflecting substantial change activity. This study is part of the global effort to build evidence for infectious disease interventions.
Status Flow
Change History
12 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE1/PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE1/PHASE2
Phase: PHASE1_PHASE2 → PHASE1/PHASE2
-
Nov 2022 — Jul 2024 [monthly]
Completed PHASE1_PHASE2
-
Jul 2022 — Nov 2022 [monthly]
Completed PHASE1_PHASE2
-
May 2022 — Jul 2022 [monthly]
Completed PHASE1_PHASE2
▶ Show 7 earlier versions
-
Apr 2022 — May 2022 [monthly]
Completed PHASE1_PHASE2
-
Mar 2021 — Apr 2022 [monthly]
Completed PHASE1_PHASE2
Phase: PHASE3 → PHASE1_PHASE2
-
Jan 2021 — Mar 2021 [monthly]
Completed PHASE3
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE3
-
Oct 2017 — Jun 2018 [monthly]
Completed PHASE3
Phase: PHASE1_PHASE2 → PHASE3
-
Feb 2017 — Oct 2017 [monthly]
Completed PHASE1_PHASE2
-
Jan 2017 — Feb 2017 [monthly]
Completed PHASE1_PHASE2
First recorded
Jul 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 .