Feasibility Study of a Vaginal Ring for Delivery of TMC120 (Dapivirine)

This study has been completed.
Sponsor:
Collaborator:
Tibotec Pharmaceutical Limited
Information provided by:
International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier:
NCT00700284
First received: June 16, 2008
Last updated: August 31, 2009
Last verified: August 2009

June 16, 2008
August 31, 2009
October 2004
January 2005   (final data collection date for primary outcome measure)
  • safety and tolerability of a vaginal ring containing TMC120 (dapivirine) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • TMC120 (dapivirine) concentrations in vaginal fluids, vaginal and cervical epithelial tissue, and plasma [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00700284 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
  • Drug: placebo vaginal ring
    vaginal ring containing no TMC120 (dapivirine)
  • Drug: TMC120 (dapivirine) vaginal ring
    vaginal ring containing 120 mg TMC120 (dapivirine)
  • Placebo Comparator: A
    Intervention: Drug: placebo vaginal ring
  • Experimental: B
    Intervention: Drug: TMC120 (dapivirine) vaginal ring
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
January 2005
January 2005   (final data collection date for primary outcome measure)

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
Female
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00700284
IPM 001, TMC120-C130
No
Zeda Rosenberg ScD, International Partnership for Microbicides
International Partnership for Microbicides, Inc.
Tibotec Pharmaceutical Limited
Principal Investigator: Dr Luc Van Bortel Drug Research Unit, UZ Gent
International Partnership for Microbicides, Inc.
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP