NCT01731574

DDI Potential: Dapivirine Vaginal Ring and Miconazole Nitrate

An Open-label, Randomized, Three-period Crossover Trial in Healthy HIV-negative Women to Assess the Drug-drug Interaction Between Dapivirine Vaginal Ring-004 and Miconazole Nitrate

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: International Partnership for Microbicides, Inc. · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

• HIV

Interventions

Type	Name	Description
DRUG	dapivirine
DRUG	miconazole

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2012-11-22
• Last updated: 2017-09-08

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study