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Clinical Trials

MainTitle

A Safety Study of Dapivirine (TMC120) Vaginal Microbicide Gel 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
NCT00309205

First received: March 30, 2006
Last updated: August 31, 2009
Last Verified: August 2009
History of Changes
Purpose

Purpose

Approximately 36 HIV-negative women, aged >18 and < 50, will be enrolled in this study. Each volunteer will have a 2:1 chance of receiving dapivirine gel versus placebo. The volunteers will receive investigational product for a total of 42 days.

Condition Intervention Phase
HIV Infections
HIV-1

Drug : dapivirine (TMC120) vaginal gel
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Phase I/II Single-Centre Double-Blinded Randomized Study of the Safety and Tolerability of TMC120 Vaginal Microbicide Gel vs. HEC-Based Universal Placebo Gel in Healthy HIV-Negative Women.

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

Primary Outcome Measures

  • Local and systemic safety and tolerability.

Enrollment: 36
Study Start Date: December 2005

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 50 Years  
Sexes Eligible for Study: Female  
Accepts Healthy Volunteers: Yes  

Criteria

Inclusion Criteria:

  • HIV-negative
  • Willing to participate and sign an informed consent form
  • Willing to be tested for HIV, use an experimental vaginal gel, and to be randomized to a study group that includes the possibility of being assigned to a placebo group.
  • Willing to use two forms of contraception during the study
  • Willing to undergo pelvic examinations with colposcopy and photographic documentation according to the protocol throughout the study.
  • Have a regular menstrual cycle defined as having a minimum of 21 days and a maximum of 36 days between menses


Exclusion Criteria:
  • Currently pregnant or breast-feeding
  • Clinically detectable genital abnormality on the vulva, vaginal walls or cervix
  • Laboratory confirmed gonorrhea, chlamydia, trichomonas, syphilis, or vaginal candidiasis or clinically diagnosed GUD or active HSV-2 lesion
  • Breakthrough bleeding or gynecologic surgery within 60 days prior to randomization
  • Symptomatic bacterial vaginosis at Screening and unwilling to undergo treatment.
  • Women who require treatment for tuberculosis (TB) within 21 days prior to
randomization.

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: NCT00309205

Locations

Belgium
SGS Biopharma - Research Unit Stuivenberg
Antwerp, Belgium, 2060

Sponsors and Collaborators

International Partnership for Microbicides, Inc.

Investigators

Study Director: Zeda Rosenberg, ScD IPM
More Information

More Information


Responsible Party: Zeda Rosenberg ScD, International Partnership for Microbicides  
ClinicalTrials.gov Identifier: NCT00309205   History of Changes  
Other Study ID Numbers: IPM005B  
Study First Received: March 30, 2006  
Last Updated: August 31, 2009  

Keywords provided by International Partnership for Microbicides, Inc.:

HIV seronegativity

Additional relevant MeSH terms:
HIV Infections
Anti-Infective Agents

ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.