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

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

Condition Intervention Phase
Bacterial Vaginosis
Trichomonas Vaginitis
Urogenital Diseases
Drug: Metronidazole gel versus placebo gel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Prevalence of bacterial vaginosis
  • Reported genitourinary symptoms

Study Start Date: January 2003
Estimated Study Completion Date: March 2005
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.

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female

Inclusion Criteria:

Nonpregnant HIV-Uninfected HIV-Infected

Exclusion Criteria:


  Contacts and Locations
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Please refer to this study by its identifier: NCT00140764

Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Principal Investigator: Taha E Taha, MD PHD Johns Hopkins Bloomberg School of Public Health
  More Information Identifier: NCT00140764     History of Changes
Other Study ID Numbers: METRO STUDY 
Study First Received: August 30, 2005
Last Updated: August 9, 2011
Health Authority: Malawi: College of Medicine Research and Ethics Committee
United States: Institutional Review Board

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
Genitourinary symptoms

Additional relevant MeSH terms:
Trichomonas Vaginitis
Vaginosis, Bacterial
Bacterial Infections
Genital Diseases, Female
Parasitic Diseases
Protozoan Infections
Trichomonas Infections
Vaginal Diseases
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents processed this record on May 26, 2016