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

This study has been completed.
Sponsor:
Information provided by:
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00140764
First received: August 30, 2005
Last updated: August 9, 2011
Last verified: August 2011

August 30, 2005
August 9, 2011
January 2003
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  • Prevalence of bacterial vaginosis
  • Reported genitourinary symptoms
Same as current
Complete list of historical versions of study NCT00140764 on ClinicalTrials.gov Archive Site
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Intravaginal Treatment of Disturbances of Vaginal Flora Among HIV Infected and Uninfected Women in Malawi
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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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Bacterial Vaginosis
  • Trichomonas Vaginitis
  • Urogenital Diseases
Drug: Metronidazole gel versus placebo gel
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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March 2005
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Inclusion Criteria:

Nonpregnant HIV-Uninfected HIV-Infected

Exclusion Criteria:

Pregnant

Female
18 Years to 55 Years
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Contact information is only displayed when the study is recruiting subjects
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NCT00140764
METRO STUDY
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Johns Hopkins Bloomberg School of Public Health
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Principal Investigator: Taha E Taha, MD PHD Johns Hopkins Bloomberg School of Public Health
Johns Hopkins Bloomberg School of Public Health
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP