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

This study has been completed.

First Received: August 30, 2005 Last Updated: November 21, 2005 History of Changes

Sponsored by:	Johns Hopkins Bloomberg School of Public Health
Information provided by:	Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:	NCT00140764

Purpose

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Metronidazole hydrochloride Metronidazole phosphate Metronidazole

U.S. FDA Resources

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.

Eligibility

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

Criteria

Inclusion Criteria:

Nonpregnant HIV-Uninfected HIV-Infected

Exclusion Criteria:

Pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00140764

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

More Information

No publications provided

Study ID Numbers:	METRO STUDY
Study First Received:	August 30, 2005
Last Updated:	November 21, 2005
ClinicalTrials.gov Identifier:	NCT00140764 History of Changes
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

Study placed in the following topic categories:

Bacterial Infections
Protozoan Infections
Metronidazole
Acquired Immunodeficiency Syndrome
Vaginitis
Trichomonas Infections
Vaginal Diseases

Genital Diseases, Female
Vaginosis, Bacterial
Radiation-Sensitizing Agents
HIV Infections
Parasitic Diseases
Trichomonas Vaginitis

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
Protozoan Infections
Metronidazole
Antiprotozoal Agents
Physiological Effects of Drugs
Vaginitis
Trichomonas Infections
Mastigophora Infections
Vaginal Diseases

Pharmacologic Actions
Genital Diseases, Female
Antiparasitic Agents
Vaginosis, Bacterial
Radiation-Sensitizing Agents
Therapeutic Uses
Sarcomastigophora Infections
Parasitic Diseases
Trichomonas Vaginitis

ClinicalTrials.gov processed this record on July 02, 2009