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

• Sponsor: Johns Hopkins Bloomberg School of Public Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT00140764
• Collaborator: (none)
• Duration (Months): 26

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bacterial Vaginosis; Trichomonas Vaginitis; Urogenital Diseases	Drug: Metronidazole gel versus placebo gel	Phase 3

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.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double
• Primary Purpose: Treatment
• Study Start Date: Jan 1, 2003
• Study Completion Date: Mar 1, 2005

Outcome Measures

Primary Outcome Measures

1. Prevalence of bacterial vaginosis []

2. Reported genitourinary symptoms []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Female

Inclusion Criteria:

Nonpregnant HIV-Uninfected HIV-Infected

Exclusion Criteria:

Pregnant

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Johns Hopkins Bloomberg School of Public Health

Investigators

• Principal Investigator: Taha E Taha, MD PHD, Johns Hopkins Bloomberg School of Public Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00140764
• Other Study ID Numbers: METRO STUDY
• First Posted: Sep 1, 2005
• Last Update Posted: Aug 10, 2011
• Last Verified: Aug 1, 2011

• Keywords provided by , ,: Genitourinary symptoms
• Additional relevant MeSH terms: Vaginosis, Bacterial; Trichomonas Vaginitis; Vaginitis; Metronidazole

Study Results

No Results Posted as of Aug 10, 2011