Status:
COMPLETED
Safety and Feasibility Study of Dapivirine (TMC120) Vaginal Ring in Belgium
Lead Sponsor:
International Partnership for Microbicides, Inc.
Collaborating Sponsors:
Tibotec Pharmaceutical Limited
Conditions:
HIV Infections
Eligibility:
FEMALE
18-50 years
Phase:
PHASE1
Brief Summary
This Phase I trial will assess the feasibility of using a vaginal ring to deliver the candidate microbicide dapivirine (TMC120) for 7 days. The study population will consist of 13 healthy, sexually ab...
Eligibility Criteria
Inclusion
- Female, age 18-50 years
- Willing and able to provide written informed consent
- HIV-uninfected and otherwise healthy
- Willing to abstain from sexual activity and from use of vaginal products while participating in the study
- Currently using oral contraceptives for pregnancy prevention
- Willing to use oral contraceptives as needed to avoid menstruation while taking part in this study
Exclusion
- History of allergy to TMC120 or to the constituents of the vaginal ring
- History of diagnosis of and/or treatment for a sexually transmitted disease within the last three months
- History of genital tract surgery within the last month
- Currently pregnant or breastfeeding, or within two months of last pregnancy outcome
- Currently or within one month of participating in any other clinical research study
- Current vulvar or vaginal symptoms / abnormalities that could influence the study results
- Current non-iatrogenic pelvic/colposcopic exam findings involving deep epithelial disruption
- Current diagnosis of any genital infection
- Smoking more than 10 cigarettes / day
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00332995
Start Date
July 1 2005
End Date
August 1 2005
Last Update
September 1 2009
Active Locations (1)
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1
Drug Research Unit Gent
Ghent, Belgium, 9000