Back to resultsIntravaginal 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
About this trial
This is an interventional treatment trial for Bacterial Vaginosis focused on measuring Genitourinary symptoms
Eligibility Criteria
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
NCT ID
NCT00140764
First Posted
August 30, 2005
Last Updated
August 9, 2011
Sponsor
Johns Hopkins Bloomberg School of Public Health
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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