DDI Potential: Dapivirine Vaginal Ring and Miconazole Nitrate
NCT01731574 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2017-09-08
Summary
This trial will investigate the potential drug-drug interaction between dapivirine vaginal Ring-004 and vaginally administered miconazole nitrate, and will evaluate the safety of co-administration of the dapivirine vaginal ring and miconazole nitrate in healthy, HIV-negative women.
Conditions
Interventions
- DRUG
-
dapivirine
- DRUG
-
miconazole
Sponsors & Collaborators
-
International Partnership for Microbicides, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 40 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-12-31
- Primary Completion
- 2013-10-31
- Completion
- 2013-10-31
- FDA Drug
- Yes
Countries
- Belgium
More Related Trials
-
Phase 3 Safety and Effectiveness Trial of Dapivirine Vaginal Ring for Prevention of HIV-1 in Women
NCT01617096 ·Status: COMPLETED ·Phase: PHASE3
-
A Pharmacokinetic Study of Dapivirine Vaginal Rings in Belgium
NCT00469768 ·Status: COMPLETED ·Phase: PHASE1
-
A Safety and Efficacy Trial of Dapivirine Vaginal Ring in Africa
NCT01337583 ·Status: WITHDRAWN ·Phase: PHASE3
-
A Safety and Efficacy Trial of Dapivirine Vaginal Ring in Africa
NCT01337570 ·Status: WITHDRAWN ·Phase: PHASE3
-
Safety and Efficacy Trial of a Dapivirine Vaginal Matrix Ring in Healthy HIV-Negative Women
NCT01539226 ·Status: COMPLETED ·Phase: NA
-
Expanded Use PK of Dapivirine Vaginal Ring
NCT01952561 ·Status: COMPLETED ·Phase: PHASE1
-
A Safety Study of Dapivirine Vaginal Ring in Africa
NCT01071174 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Study of Dapivirine Vaginal Ring (VR) in Adolescents
NCT02028338 ·Status: COMPLETED ·Phase: PHASE2
-
An Expanded Safety Study of Dapivirine Gel 4759 in Africa
NCT00917891 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Safety and Pharmacokinetics of Dapivirine/Maraviroc Vaginal Ring
NCT01363037 ·Status: COMPLETED ·Phase: PHASE1
-
A Safety and Pharmacokinetic Study for Dapivirine and Maraviroc Gel in Belgium
NCT01242579 ·Status: WITHDRAWN ·Phase: PHASE1
-
Safety and Feasibility Study of Dapivirine (TMC120) Vaginal Ring in Belgium
NCT00332995 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase I Pharmacokinetics and Safety Study of Two Dapivirine Intravaginal Gels
NCT00613249 ·Status: COMPLETED ·Phase: PHASE1
-
A Safety Study of Dapivirine (TMC120) Vaginal Microbicide Gel in Belgium
NCT00309205 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
An Expanded Safety Study of Dapivirine Gel 4789 in Africa
NCT00917904 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Phase 1, Randomized Pharmacokinetics and Safety Study of Extended Duration Dapivirine Vaginal Rings
NCT03234400 ·Status: COMPLETED ·Phase: PHASE1
-
A Safety Study of Two Dapivirine (TMC120) Vaginal Gels in the United States
NCT00799058 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
An Imaging Trial of the Distribution of Topical Gel Formulations in the Human Vagina
NCT00214747 ·Status: UNKNOWN ·Phase: PHASE1
-
PK and Safety Study of Vaginal Rings Containing Dapivirine and Levonorgestrel
NCT02855346 ·Status: COMPLETED ·Phase: PHASE1
-
Feasibility Study of a Vaginal Ring for Delivery of TMC120 (Dapivirine)
NCT00700284 ·Status: COMPLETED ·Phase: PHASE1
-
A Safety and Tolerability Study of Dapivirine (TMC120) Vaginal Microbicide Gel
NCT00303576 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Trial to Assess the Continued Safety of and Adherence to a Vaginal Ring Containing Dapivirine in Women
NCT02858037 ·Status: COMPLETED ·Phase: PHASE3
-
Topical Metronidazole and Miconazole Co-formulated Vaginal Suppositories for Preventing Vaginal Infections in HIV-seronegative Women
NCT01230814 ·Status: COMPLETED ·Phase: PHASE2
-
Assessing the Safety of Dapivirine Gel and Film Formulations
NCT01548560 ·Status: COMPLETED ·Phase: PHASE1
-
PK Study of 90-Day Use of Vaginal Rings Containing Dapivirine and Levonorgestrel
NCT03467347 ·Status: COMPLETED ·Phase: PHASE1