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

Sponsor
International Partnership for Microbicides, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00303576
Collaborator
(none)
112
Enrollment
4
Locations
9
Duration (Months)
28
Patients Per Site
3.1
Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:
Interventional
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 :
Oct 1, 2005
Study Completion Date :
Jul 1, 2006

Outcome Measures

Primary Outcome Measures

  1. Local and systemic safety and tolerability. []

Eligibility Criteria

Criteria

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

Locations

Site City State Country Postal Code
1 Projet Ubuzima Kigali Rwanda
2 Reproductive Health Research Unit - Sheshisani IPM Clinic Yeoville Johannesburg South Africa
3 Farmovs-Parexel Bloemfontein South Africa
4 Kilimanjaro Reproductive Health Program Moshi Tanzania

Sponsors and Collaborators

  • International Partnership for Microbicides, Inc.

Investigators

  • Study Director: Zeda Rosenberg, ScD, IPM

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00303576
Other Study ID Numbers:
  • IPM003
First Posted:
Mar 17, 2006
Last Update Posted:
Jul 31, 2006
Last Verified:
Jul 1, 2006
Keywords provided by , ,
HIV-1
HIV Seronegativity
Additional relevant MeSH terms:
HIV Infections
Dapivirine

Study Results

No Results Posted as of Jul 31, 2006