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

Bacterial Vaginosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00140764
• Other study ID #: METRO STUDY
• Status: Completed
• Phase: Phase 3
• First received: August 30, 2005
• Last updated: August 9, 2011
• Start date: January 2003
• Est. completion date: March 2005

Study information

• Verified date: August 2011
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malawi: College of Medicine Research and Ethics CommitteeUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2005
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

Nonpregnant HIV-Uninfected HIV-Infected

Exclusion Criteria:

Pregnant

Study Design

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

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Trichomonas Vaginitis
• Urogenital Diseases
• Vaginosis, Bacterial

Intervention

Drug:
• Metronidazole gel versus placebo gel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of bacterial vaginosis
Primary	Reported genitourinary symptoms