Status:
COMPLETED
Feasibility Study of a Vaginal Ring for Delivery of TMC120 (Dapivirine)
Lead Sponsor:
International Partnership for Microbicides, Inc.
Collaborating Sponsors:
Tibotec Pharmaceutical Limited
Conditions:
HIV Infections
Eligibility:
FEMALE
18-50 years
Phase:
PHASE1
Brief Summary
The purpose of this trial was to evaluate the safety and feasibility of using a vaginal ring to deliver the candidate microbicide TMC120 (dapivirine). Twelve women initially underwent 7-day exposure t...
Eligibility Criteria
Inclusion
- Female, 18-50 years, inclusive
- Willing and able to provide written informed consent
- HIV-uninfected and otherwise healthy
- Willing to abstain from sexual activity and use of vaginal products while participating in the trial
- Currently using oral contraceptives for pregnancy prevention
- Willing to use oral contraceptives as needed to avoid menstruation while taking part in this trial
Exclusion
- History of alcoholism, drug abuse, psychosis, antagonistic personality, poor motivation, or other emotional or intellectual problems that are likely to invalidate the informed consent process or adversely impact compliance with protocol requirements.
- History of allergy to TMC120 or to the constituents of the vaginal ring.
- History of hypersensitivity to propofol, or other contraindication to general anesthesia or sedation
- 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 trial
- Current (during screening) diagnosis of any genital infection
- Current vulvar of vaginal symptoms
- Current non-iatrogenic pelvic/colposcopic exam findings involving deep epithelial disruption
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2005
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00700284
Start Date
October 1 2004
End Date
January 1 2005
Last Update
September 1 2009
Active Locations (1)
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1
Drug Research Unit, UZ Gent
Ghent, Belgium, 9000