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Intravaginal Treatment of Disturbances of Vaginal Flora Among HIV Infected and Uninfected Women in Malawi

Primary Purpose

Bacterial Vaginosis, Trichomonas Vaginitis, Urogenital Diseases

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Metronidazole gel versus placebo gel
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Vaginosis focused on measuring Genitourinary symptoms

Eligibility Criteria

18 Years - 55 Years (Adult)Female

Inclusion Criteria: Nonpregnant HIV-Uninfected HIV-Infected Exclusion Criteria: Pregnant

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Prevalence of bacterial vaginosis
    Reported genitourinary symptoms

    Secondary Outcome Measures

    Full Information

    First Posted
    August 30, 2005
    Last Updated
    August 9, 2011
    Sponsor
    Johns Hopkins Bloomberg School of Public Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00140764
    Brief Title
    Intravaginal Treatment of Disturbances of Vaginal Flora Among HIV Infected and Uninfected Women in Malawi
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    March 2005 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Johns Hopkins Bloomberg School of Public Health

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this intervention is to find out whether intravaginal treatment with a gel containing an antibiotic (metronidazole), compared to a similar placebo gel (without antibiotic), can reduce the frequency of bacterial vaginosis, a common vaginal infection among African women who are HIV uninfected or HIV infected. The study will also determine the effect of these vaginal gels on genitourinary symptoms.
    Detailed Description
    This is a phase 3, randomized, double masked, two arms study conducted in Malawi, Southeast Africa. The study is conducted among nonpregnant HIV infected or uninfected women of reproductive age. Intermittent mass treatment approaches are followed where women are randomized to antibiotic intravaginal treatment or placebo at enrollment. Women receive assigned product every three months for one year.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bacterial Vaginosis, Trichomonas Vaginitis, Urogenital Diseases
    Keywords
    Genitourinary symptoms

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    Double
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Metronidazole gel versus placebo gel
    Primary Outcome Measure Information:
    Title
    Prevalence of bacterial vaginosis
    Title
    Reported genitourinary symptoms

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Eligibility Criteria
    Inclusion Criteria: Nonpregnant HIV-Uninfected HIV-Infected Exclusion Criteria: Pregnant
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Taha E Taha, MD PHD
    Organizational Affiliation
    Johns Hopkins Bloomberg School of Public Health
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30002871
    Citation
    Aizire J, Dadabhai S, Taulo F, Makanani B, Gadama L, Sun J, Tsui A, Taha TE. Use of effective family planning methods and frequency of sex among HIV-infected and HIV-uninfected African women. Contracept Reprod Med. 2018 Jul 9;3:10. doi: 10.1186/s40834-018-0063-z. eCollection 2018.
    Results Reference
    derived

    Learn more about this trial

    Intravaginal Treatment of Disturbances of Vaginal Flora Among HIV Infected and Uninfected Women in Malawi

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