Trial | NCT00700284  Report issue

Title

Feasibility Study of a Vaginal Ring for Delivery of TMC120 (Dapivirine)
Phase I Study of a Vaginal Ring for Delivery of TMC120 (Dapivirine) as a Vaginal Microbicide

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    dapivirine ...

  • Study Participants

    12
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 to a placebo ring containing no investigational agent. They then underwent 7-day exposure to a ring containing 120 mg of TMC120 (dapivirine). Feasibility was assessed in terms of safety and tolerability as well as drug delivery.
Study Started
Oct 31
2004
Primary Completion
Jan 31
2005
Study Completion
Jan 31
2005
Last Update
Sep 01
2009
Estimate

Drug placebo vaginal ring

vaginal ring containing no TMC120 (dapivirine)

Drug TMC120 (dapivirine) vaginal ring

vaginal ring containing 120 mg TMC120 (dapivirine)

A Placebo Comparator

B Experimental

Criteria 

Inclusion Criteria:

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 Criteria:

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
No Results Posted