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
1 other identifier
interventional
12
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 hiv-infections
Started Oct 2004
Shorter than P25 for phase_1 hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 16, 2008
CompletedFirst Posted
Study publicly available on registry
June 18, 2008
CompletedSeptember 1, 2009
August 1, 2009
3 months
June 16, 2008
August 31, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
safety and tolerability of a vaginal ring containing TMC120 (dapivirine)
7 days
TMC120 (dapivirine) concentrations in vaginal fluids, vaginal and cervical epithelial tissue, and plasma
7 days
Study Arms (2)
A
PLACEBO COMPARATORB
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Drug Research Unit, UZ Gent
Ghent, 9000, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr Luc Van Bortel
Drug Research Unit, UZ Gent
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 16, 2008
First Posted
June 18, 2008
Study Start
October 1, 2004
Primary Completion
January 1, 2005
Study Completion
January 1, 2005
Last Updated
September 1, 2009
Record last verified: 2009-08