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Clinical Trials

MainTitle

A Safety and Tolerability Study of Dapivirine (TMC120) Vaginal Microbicide Gel

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


Information provided by (Responsible Party)
International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier
NCT00303576

First received: March 15, 2006
Last updated: July 28, 2006
Last Verified: July 2006
History of Changes
Purpose

Purpose

Approximately 112 HIV-negative women, aged 18 to 50, will be enrolled in this multicenter study at four sites. Volunteers will be randomized to dapivirine (TMC120) vaginal gel or matching placebo gel. The volunteers will receive investigational product for a total of 42 days. Volunteers will be monitored on days 7, 28 and 42 for safety, tolerability and compliance.

Condition Intervention Phase
HIV Infections

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 Double-Blind, Randomized Study of the Safety, Tolerability and Systemic Absorption of TMC120 Vaginal Microbicide Gel and Matching Placebo 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: 112
Study Start Date: October 2005
Study Completion Date: July 2006

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
  • 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.
  • Willing to abstain from using any vaginal product (other than the study product or placebo).
  • Willing to be sexually abstinent from randomization until completion of Day 7 evaluations.


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 genital ulcer disease or active HSV-2 lesions.
  • Breakthrough bleeding or gynecologic surgery within 60 days prior to randomization.
  • Symptomatic bacterial vaginosis 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: NCT00303576

Locations

Rwanda
Projet Ubuzima
Kigali, Rwanda
South Africa
Reproductive Health Research Unit - Sheshisani IPM Clinic
Yeoville, Johannesburg, South Africa
Farmovs-Parexel
Bloemfontein, South Africa
Tanzania
Kilimanjaro Reproductive Health Program
Moshi, Tanzania

Sponsors and Collaborators

International Partnership for Microbicides, Inc.

Investigators

Study Director: Zeda Rosenberg, ScD IPM
More Information

More Information


Responsible Party: International Partnership for Microbicides, Inc.  
ClinicalTrials.gov Identifier: NCT00303576   History of Changes  
Other Study ID Numbers: IPM003  
Study First Received: March 15, 2006  
Last Updated: July 28, 2006  

Keywords provided by International Partnership for Microbicides, Inc.:

HIV-1
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Anti-Infective Agents

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