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

Johns Hopkins Bloomberg School of Public Health0 sitesJanuary 2003

ConditionsBacterial Vaginosis Trichomonas Vaginitis Urogenital Diseases

DrugsMetronidazole gel versus placebo gel

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Bacterial Vaginosis
Sponsor: Johns Hopkins Bloomberg School of Public Health
Primary Endpoint: Prevalence of bacterial vaginosis
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2003

End Date

March 2005

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group