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

Primary Purpose

HIV Infections

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
dapivirine (TMC120) vaginal gel
Sponsored by
International Partnership for Microbicides, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV-1, HIV Seronegativity

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Local and systemic safety and tolerability.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 17, 2006
    Last Updated
    December 8, 2015
    Sponsor
    International Partnership for Microbicides, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00304668
    Brief Title
    A Safety Study of Dapivirine (TMC120) Vaginal Microbicide Gel in South Africa
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2006
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    International Partnership for Microbicides, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Infections
    Keywords
    HIV-1, HIV Seronegativity

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    dapivirine (TMC120) vaginal gel
    Primary Outcome Measure Information:
    Title
    Local and systemic safety and tolerability.

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zeda Rosenberg, ScD
    Organizational Affiliation
    IPM
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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