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A Safety Study of Dapivirine (TMC120) Vaginal Microbicide Gel in South Africa

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier:
NCT00304668
First received: March 17, 2006
Last updated: May 24, 2006
Last verified: May 2006
History of Changes
  Purpose

Approximately 42 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-002 versus placebo. The volunteers will receive investigational product for a total of 42 days.


Condition Intervention Phase
HIV Infections
 Drug: dapivirine (TMC120) vaginal gel
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 (TMC120 Gel-002) Vs. HEC-Based Universal Placebo Gel in Healthy HIV-Negative Women.

Resource links provided by NLM:

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

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

Primary Outcome Measures:
  • Local and systemic safety and tolerability.

Estimated Enrollment: 42
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00304668

Sponsors and Collaborators
International Partnership for Microbicides, Inc.
Investigators
Study Director: Zeda Rosenberg, ScD IPM
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00304668     History of Changes
Other Study ID Numbers: IPM005A
Study First Received: March 17, 2006
Last Updated: May 24, 2006
Health Authority: South Africa: Medicines Control Council

Keywords provided by International Partnership for Microbicides, Inc.:
HIV-1
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
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 13, 2013