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

Condition(s) targeted: Bacterial Vaginosis; Trichomonas Vaginitis; Urogenital Diseases

Intervention: Metronidazole gel versus placebo gel (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Johns Hopkins Bloomberg School of Public Health

Official(s) and/or principal investigator(s):
Taha E Taha, MD PHD, Principal Investigator, Affiliation: Johns Hopkins Bloomberg School of Public Health

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.

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

Primary outcome:

Prevalence of bacterial vaginosis

Reported genitourinary symptoms

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.

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

Nonpregnant HIV-Uninfected HIV-Infected

Exclusion Criteria:

Pregnant

Starting date: January 2003
Ending date: March 2005
Last updated: November 21, 2005