A Pharmacokinetic Study of Dapivirine Vaginal Rings in Belgium

This study has been completed.
Sponsor:
Information provided by:
International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier:
NCT00469768
First received: May 3, 2007
Last updated: August 31, 2009
Last verified: August 2009

May 3, 2007
August 31, 2009
May 2007
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Complete list of historical versions of study NCT00469768 on ClinicalTrials.gov Archive Site
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A Pharmacokinetic Study of Dapivirine Vaginal Rings in Belgium
A Double-blind, Randomized, Placebo-controlled Safety and Pharmacokinetic Study in Healthy HIV-negative Women to Assess the Delivery of Dapivirine From Matrix and Reservoir Intravaginal Rings Each Containing 25 mg of Dapivirine

IPM 018 is a double-blind, randomized, placebo-controlled study conducted at one site in Belgium among 24 healthy, HIV-negative women to evaluate dapivirine release for 28 days from matrix and reservoir intravaginal rings, each containing 25 mg of dapivirine, and to assess safety and tolerability compared to placebo

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
HIV Infections
  • Drug: dapivirine reservoir intravaginal ring
    a silicone elastomer reservoir ring containing 25mg of dapivirine
  • Drug: dapivirine matrix intravaginal ring
    a silicone elastomer matrix intravaginal ring containing 25mg of dapivirine
  • Other: placebo intravaginal ring
    a silicone elastomer intravaginal ring containing no dapivirine
  • Experimental: A
    Intervention: Drug: dapivirine matrix intravaginal ring
  • Experimental: B
    Intervention: Drug: dapivirine reservoir intravaginal ring
  • Placebo Comparator: C
    Intervention: Other: placebo intravaginal ring
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
August 2007
Not Provided

Inclusion Criteria:

  • Women between 18 and 35 years of age
  • Willing and able to give written informed consent
  • Available for all visits and consent to follow all procedures scheduled for the study
  • Healthy and HIV-negative as determined by a HIV-1 ELISA test at time of enrollment;
  • Willing to abstain from sexual activity for the duration of the study
  • Willing to use oral contraceptives to avoid menstruation while taking part in this study or on long-acting progestins for 6 months prior to enrollment
  • Upon pelvic / speculum examination at enrollment, the cervix and vagina appear normal
  • Willing to refrain from use of vaginal products or objects for the duration of the study.

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 sensitivity / allergy to latex, dapivirine or to the constituents of the vaginal ring (i.e. silicone elastomer)
  • Currently pregnant or breast-feeding, or within three months of last pregnancy outcome
  • Currently or within one month of participating in any other clinical research study
  • History or diagnosis of and / or treatment for a sexually transmitted disease within the last three months
  • History of genital tract surgery within the last month
  • Current diagnosis of sexually transmitted infections (Gonorrhea, Chlamydia and Trichomonas)
  • Current vulvar or vaginal symptoms / abnormalities that could influence the study results
  • History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding or urethral obstruction within the last three months;
  • Smoking more than 10 cigarettes per day
Female
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00469768
IPM 018
No
Zeda Rosenberg ScD, International Partnership for Microbicides
International Partnership for Microbicides, Inc.
Not Provided
Study Director: Dr. Annalene Nel International Partnership for Microbicides (IPM)
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