Trial record 8 of 28 for:    " May 01, 2007":" May 31, 2007"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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
  Purpose

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


Condition Intervention Phase
HIV Infections
Drug: dapivirine reservoir intravaginal ring
Drug: dapivirine matrix intravaginal ring
Other: placebo intravaginal ring
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by International Partnership for Microbicides, Inc.:

Enrollment: 24
Study Start Date: May 2007
Study Completion Date: August 2007
Arms Assigned Interventions
Experimental: A Drug: dapivirine matrix intravaginal ring
a silicone elastomer matrix intravaginal ring containing 25mg of dapivirine
Experimental: B Drug: dapivirine reservoir intravaginal ring
a silicone elastomer reservoir ring containing 25mg of dapivirine
Placebo Comparator: C Other: placebo intravaginal ring
a silicone elastomer intravaginal ring containing no dapivirine

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00469768

Locations
Belgium
Drug Research Unit Ghent (D.R.U.G.)
Ghent, Belgium, 9000
Sponsors and Collaborators
International Partnership for Microbicides, Inc.
Investigators
Study Director: Dr. Annalene Nel International Partnership for Microbicides (IPM)
  More Information

Additional Information:
No publications provided

Responsible Party: Zeda Rosenberg ScD, International Partnership for Microbicides
ClinicalTrials.gov Identifier: NCT00469768     History of Changes
Other Study ID Numbers: IPM 018
Study First Received: May 3, 2007
Last Updated: August 31, 2009
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Keywords provided by International Partnership for Microbicides, Inc.:
HIV-1 infection
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on April 17, 2014