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MainTitle

A Pharmacokinetic Study of Dapivirine Vaginal Rings in Belgium

This study has been completed
Sponsor
International Partnership for Microbicides, Inc.

Information provided by (Responsible Party)
International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier
NCT00469768

First received: May 3, 2007
Last updated: August 31, 2009
Last Verified: August 2009
History of Changes
Purpose

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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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

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

Eligibility

Ages Eligible for Study: 18 Years to 35 Years  
Sexes 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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

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

More Information

Additional Information:

Drug Research Unit Ghent website

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  

Keywords provided by International Partnership for Microbicides, Inc.:

HIV-1 infection
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections

ClinicalTrials.gov processed this data on October 23, 2017
This information is provided by ClinicalTrials.gov.

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