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B3e A Randomized Treatment Trial: 2 Gram STAT Versus 7 DAY 500 MG BID Dose of Metronidazole (MTZ) for the Treatment of Trichomonas Vaginalis Among HIV-Infected Women

Tuesday, March 9, 2010: 4:15 PM
Grand Ballroom A (M4) (Omni Hotel)
Patricia Kissinger, PhD1, Leandro A. Mena, MD, MPH2, Judy Levison, MD3, Rebecca Clark, MD, PhD4, Megan Gatski, MSN1, Harold Henderson, MD5, Norine Schmidt, MPH1, Susan Rosenthal, PhD6, Leann Myers, PhD7 and David H. Martin, MD8, 1School of Public Health and Tropical Medicine, Department of Epidemiology, Tulane University, New Orleans, LA, 2Division of Infectious Diseases, University of Mississippi Medical Center and Mississippi State Department of Health, Jackson, MS, 3Department of Obstetrics and Gynecology, Department of Family and Community Medicine, Baylor College of Medicine, Houston, TX, 4Section of Infectious Diseases, Louisiana State University, New Orleans, LA, 5Division of Infectious Diseases, University of Mississippi Medical Center, Jackson, MS, 6Department of Pediatrics, Columbia University Medical Center College of Physicians and Surgeons, New York, NY, 7School of Public Health and Tropical Medicine, Department of Biostatistics, Tulane University, New Orleans, LA, 8Department of Medicine, Section of infectious Diseases, Louisiana State University Health Sciences Center, New Orleans, LA
Audio File Recorded presentation

Background: Repeated infections with Trichomonas vaginalis (TV) among HIV+ women are common, have been associated with higher rates of vaginal shedding of HIV, and may in part be due to increased treatment failure rates of the standard 2 gram STAT dose of MTZ.

Objectives: To determine if the 2 gram STAT dose of MTZ is as effective as the 7 day 500 mg BID dose for treatment of TV among HIV-infected women.

Methods: A multi-centered phase IV equivalency trial was conducted in three US cities.   TV was diagnosed by culture. HIV+/TV+ women were randomized to receive either the 2 gram STAT dose or the 7 day 500 mg BID dose of MTZ. A test-of-cure (TOC) visit was conducted 6-12 days post-treatment.

Results: Of 270 women enrolled (mean age = 40 years, std dev = 9.4), 92.2% were African- American, 29.1% had CD4 cell counts < 200/mm3, 34.6% had plasma viral loads > 10,000 copies, and 63.5% were taking ART. There were 135 women randomized to each treatment arm, and no differences were found between arms with respect to age, race, CD4 count, viral load, ART status, clinic, sexual exposure or loss-to-follow up.  At TOC, 255 women were re-tested for TV, and 12.5% (n=32) were TV+. Women in the 7 day treatment arm had lower infection rates at TOC compared to those in the 2 gram STAT arm:  8.5% (11/130) versus 16.8% (21/125)  [R.R. 0.50 (95% CI=0.25, 0.99; P=0.045)].

Conclusions: The 7 day 500 mg BID dose of MTZ is more effective than the 2 gram STAT dose for the treatment of TV among HIV-infected women.

Implications for Programs, Policy, and/or Research: The single 2 gram MTZ dose should no longer be recommended for the treatment of TV in HIV infected women.

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