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

This study has been completed.
Sponsor:
Information provided by:
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00140764
First received: August 30, 2005
Last updated: August 9, 2011
Last verified: August 2011
  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 3

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 19, 2014