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

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ClinicalTrials.gov Identifier: NCT00303576
Recruitment Status : Completed
First Posted : March 17, 2006
Last Update Posted : July 31, 2006
Sponsor:
Information provided by:
International Partnership for Microbicides, Inc.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Drug: dapivirine (TMC120) vaginal gel Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 112 participants
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.
Study Start Date : October 2005
Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Local and systemic safety and tolerability.

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00303576     History of Changes
Other Study ID Numbers: IPM003
First Posted: March 17, 2006    Key Record Dates
Last Update Posted: July 31, 2006
Last Verified: July 2006

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

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Anti-Infective Agents