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To Assess the Drug-drug Interaction Potential Between Dapivirine Vaginal Ring-004, Containing 25 mg of Dapivirine, and Clotrimazole 10 mg/g (1%)

NCT02847286 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2017-08-30

No results posted yet for this study

Summary

A Study to assess the drug-drug interaction potential, between Dapivirine Vaginal Ring-004, containing 25 MG of Dapivirine.

Conditions

  • HIV- Prevention

Interventions

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

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
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-01
Primary Completion
2016-11-28
Completion
2016-11-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02847286 on ClinicalTrials.gov