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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00140764
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : August 10, 2011
Sponsor:
Information provided by:

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  (Clinical Trial)
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : January 2003
Estimated Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Prevalence of bacterial vaginosis
  2. Reported genitourinary symptoms

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Criteria

Inclusion Criteria:

Nonpregnant HIV-Uninfected HIV-Infected

Exclusion Criteria:

Pregnant

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00140764     History of Changes
Other Study ID Numbers: METRO STUDY
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: August 10, 2011
Last Verified: August 2011

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
Genitourinary symptoms

Additional relevant MeSH terms:
Vaginosis, Bacterial
Vaginitis
Trichomonas Infections
Trichomonas Vaginitis
Bacterial Infections
Vaginal Diseases
Genital Diseases, Female
Protozoan Infections
Parasitic Diseases
Metronidazole
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents