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

Johns Hopkins Bloomberg School of Public Health

Status and phase

Completed

Phase 3

Conditions

Urogenital Diseases

Bacterial Vaginosis

Trichomonas Vaginitis

Treatments

Drug: Metronidazole gel versus placebo gel

Study type

Interventional

Funder types

Other

Identifiers

NCT00140764

METRO STUDY

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Nonpregnant HIV-Uninfected HIV-Infected

Exclusion criteria

Pregnant