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

Tracking Information

First Received Date ^ICMJE

August 30, 2005

Last Updated Date

November 21, 2005

Start Date ^ICMJE

January 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Prevalence of bacterial vaginosis
Reported genitourinary symptoms

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00140764 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Bacterial Vaginosis
Trichomonas Vaginitis
Urogenital Diseases

Intervention ^ICMJE

Drug: Metronidazole gel versus placebo gel

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Nonpregnant HIV-Uninfected HIV-Infected

Exclusion Criteria:

Pregnant

Gender

Female

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00140764

Responsible Party

Study ID Numbers ^ICMJE

METRO STUDY

Study Sponsor ^ICMJE

Johns Hopkins Bloomberg School of Public Health

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Taha E Taha, MD PHD

Johns Hopkins Bloomberg School of Public Health

Information Provided By

Johns Hopkins Bloomberg School of Public Health

Verification Date

July 2005

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