A Safety Study of Dapivirine (TMC120) Vaginal Microbicide Gel in Belgium
NCT00309205 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2009-09-01
Summary
Approximately 36 HIV-negative women, aged \>18 and \< 50, will be enrolled in this study. Each volunteer will have a 2:1 chance of receiving dapivirine gel versus placebo. The volunteers will receive investigational product for a total of 42 days.
Conditions
- HIV Infections
- HIV-1
Interventions
- DRUG
-
dapivirine (TMC120) vaginal gel
Sponsors & Collaborators
-
International Partnership for Microbicides, Inc.
lead INDUSTRY
Principal Investigators
-
Zeda Rosenberg, ScD · Beijing Immupeutics Medicine Technology Limited
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2005-12-31
Countries
- Belgium
Study Locations
More Related Trials
-
A Phase I Pharmacokinetics and Safety Study of Two Dapivirine Intravaginal Gels
NCT00613249 ·Status: COMPLETED ·Phase: PHASE1
-
Assessing the Safety of Dapivirine Gel and Film Formulations
NCT01548560 ·Status: COMPLETED ·Phase: PHASE1
-
Dapivirine Gel Rectal Safety and PK Study
NCT03044379 ·Status: WITHDRAWN ·Phase: PHASE1
-
An Expanded Safety Study of Dapivirine Gel 4789 in Africa
NCT00917904 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
An Expanded Safety Study of Dapivirine Gel 4759 in Africa
NCT00917891 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Feasibility Study of a Vaginal Ring for Delivery of TMC120 (Dapivirine)
NCT00700284 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Pharmacokinetics of Dapivirine Vaginal Ring in Post-menopausal Women
NCT02010593 ·Status: COMPLETED ·Phase: PHASE2
-
Phase 3 Safety and Effectiveness Trial of Dapivirine Vaginal Ring for Prevention of HIV-1 in Women
NCT01617096 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy Trial of a Dapivirine Vaginal Matrix Ring in Healthy HIV-Negative Women
NCT01539226 ·Status: COMPLETED ·Phase: NA
-
A Pharmacokinetic Study of Dapivirine Vaginal Rings in Belgium
NCT00469768 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Pharmacokinetic Trial in Healthy HIV-Negative Women to Assess the Delivery of Dapivirine From a Vaginal Ring
NCT02920827 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Acceptability of a Vaginal Microbicide
NCT00111943 ·Status: COMPLETED ·Phase: PHASE2
-
An Imaging Trial of the Distribution of Topical Gel Formulations in the Human Vagina
NCT00214747 ·Status: UNKNOWN ·Phase: PHASE1
-
Interventional Study of Mucosal and Antimicrobial Responses to Repeated Vaginal Applications of Tenofovir Gel in HIV Uninfected Women
NCT00594373 ·Status: COMPLETED ·Phase: PHASE1
-
A Safety Study to Assess the Delivery of Dapivirine From a Matrix Vaginal Ring
NCT01144676 ·Status: COMPLETED ·Phase: PHASE1
-
A Safety and Pharmacokinetic Study for Dapivirine and Maraviroc Gel in Belgium
NCT01242579 ·Status: WITHDRAWN ·Phase: PHASE1
-
Study of UC-781 Vaginal Microbicide
NCT00132444 ·Status: COMPLETED ·Phase: PHASE1
-
Phase I Study of Safety and Persistence of UC-781 Vaginal Microbicide
NCT00441909 ·Status: COMPLETED ·Phase: PHASE1
-
A Safety Study Of A Single Vaginal Administration Of P2G12 Antibody In Healthy Female Subjects
NCT01403792 ·Status: COMPLETED ·Phase: PHASE1
-
Male Tolerance Study of Dapivirine Gel Following Multiple Topical Penile Exposures
NCT01277640 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluating the Safety of Tenofovir Vaginal Gel in HIV-Uninfected Pregnant Women
NCT01490671 ·Status: WITHDRAWN ·Phase: PHASE2
-
Safety, PK, and PD Study of a Vaginal Insert Containing TAF and EVG
NCT03762772 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of BufferGel in Women
NCT00000927 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Acceptability of the Anti-Microbe Vaginal Gel, PMPA Gel
NCT00028132 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Compare Three Different Formulations of Tenofovir 1% Gel When Administered Rectally
NCT01575405 ·Status: COMPLETED ·Phase: PHASE1