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

This study has been completed.

First Received on August 30, 2005. Last Updated on August 9, 2011 History of Changes

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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Trichomoniasis

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

ClinicalTrials.gov 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 Infections
Trichomonas Vaginitis
Vaginitis
Urologic Diseases
Vaginosis, Bacterial
Protozoan Infections
Parasitic Diseases
Vaginal Diseases
Genital Diseases, Female

Bacterial Infections
Metronidazole
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on February 12, 2012