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

This study has been completed.
Sponsor:
Information provided by:
International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier:
NCT00303576
First received: March 15, 2006
Last updated: July 28, 2006
Last verified: July 2006
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


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

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

Estimated Enrollment: 112
Study Start Date: October 2005
Estimated Study Completion Date: July 2006
  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
  • 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
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

No publications provided

ClinicalTrials.gov Identifier: NCT00303576     History of Changes
Other Study ID Numbers: IPM003
Study First Received: March 15, 2006
Last Updated: July 28, 2006
Health Authority: South Africa: Medicines Control Council
Tanzania: Food and Drug Authority
Rwanda: Ministry of Health

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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014