Trials / Completed
CompletedNCT02847286
To Assess the Drug-drug Interaction Potential Between Dapivirine Vaginal Ring-004, Containing 25 mg of Dapivirine, and Clotrimazole 10 mg/g (1%)
AN OPEN-LABEL, RANDOMISED TRIAL, WITH A THREE-PERIOD CROSSOVER PART IN HEALTHY HIV-NEGATIVE WOMEN TO ASSESS THE DRUG-DRUG INTERACTION POTENTIAL BETWEEN DAPIVIRINE VAGINAL RING-004, CONTAINING 25 MG OF DAPIVIRINE, AND CLOTRIMAZOLE 10 mg/g (1%) ADMINISTERED AS A VAGINAL CREAM, WITH A FOLLOW-ON PERIOD TO ASSESS THE EFFECT OF MULTIPLE RING REMOVALS AND RE-INSERTIONS DURING THE 28-DAY PERIOD OF THE DAPIVIRINE VAGINAL RING-004 USE ON THE SYSTEMIC AND LOCAL EXPOSURE AND RESIDUAL AMOUNT OF DAPIVIRINE IN USED RINGS
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- International Partnership for Microbicides, Inc. · Industry
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
A Study to assess the drug-drug interaction potential, between Dapivirine Vaginal Ring-004, containing 25 MG of Dapivirine.
Detailed description
AN OPEN-LABEL, RANDOMISED TRIAL, WITH A THREE-PERIOD CROSSOVER PART IN HEALTHY HIV-NEGATIVE WOMEN TO ASSESS THE DRUG-DRUG INTERACTION POTENTIAL BETWEEN DAPIVIRINE VAGINAL RING-004, CONTAINING 25 MG OF DAPIVIRINE, AND CLOTRIMAZOLE 10 mg/g (1%) ADMINISTERED AS A VAGINAL CREAM, WITH A FOLLOW-ON PERIOD TO ASSESS THE EFFECT OF MULTIPLE RING REMOVALS AND RE-INSERTIONS DURING THE 28-DAY PERIOD OF THE DAPIVIRINE VAGINAL RING-004 USE ON THE SYSTEMIC AND LOCAL EXPOSURE AND RESIDUAL AMOUNT OF DAPIVIRINE IN USED RINGS
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dapivirine Ring-004 | Treatment A: Dapivirine Ring-004 for 28 days |
| DRUG | Dapivirine Ring-004 for 28 days along with clotrimazole | Treatment B: Dapivirine Ring-004 for 28 days along with clotrimazole, 5 g per day for 7 days |
| DRUG | Clotrimazole | Treatment C: Clotrimazole, 5 g per day for 7 days |
Timeline
- Start date
- 2015-09-01
- Primary completion
- 2016-11-28
- Completion
- 2016-11-28
- First posted
- 2016-07-28
- Last updated
- 2017-08-30
Source: ClinicalTrials.gov record NCT02847286. Inclusion in this directory is not an endorsement.