Status and phase
Conditions
Treatments
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
Ages
Volunteers
Inclusion criteria
Nonpregnant HIV-Uninfected HIV-Infected
Exclusion criteria
Pregnant
Primary purpose
Allocation
Interventional model
Masking
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Data sourced from clinicaltrials.gov
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