A randomized treatment trial: single versus 7-day dose of metronidazole for the treatment of Trichomonas vaginalis among HIV-infected women

J Acquir Immune Defic Syndr. 2010 Dec 15;55(5):565-71. doi: 10.1097/QAI.0b013e3181eda955.


Objective: To determine if the metronidazole (MTZ) 2-gm single dose (recommended) is as effective as the 7-day 500 mg twice a day dose (alternative) for treatment of Trichomonas vaginalis (TV) among HIV+ women.

Methods: Phase IV randomized clinical trial; HIV+ women with culture confirmed TV were randomized to treatment arm: MTZ 2-gm single dose or MTZ 500 mg twice a day 7-day dose. All women were given 2-gm MTZ doses to deliver to their sex partners. Women were recultured for TV at a test-of-cure (TOC) visit occurring 6-12 days after treatment completion. TV-negative women at TOC were again recultured at a 3-month visit. Repeat TV infection rates were compared between arms.

Results: Two hundred seventy HIV+/TV+ women were enrolled (mean age = 40 years, ±9.4; 92.2% African American). Treatment arms were similar with respect to age, race, CD4 count, viral load, antiretroviral therapy status, site, and loss-to-follow up. Women in the 7-day arm had lower repeat TV infection rates at TOC [8.5% (11 of 130) versus 16.8% (21 of 125) (relative risk: 0.50, 95% confidence interval = 0.25, 1.00; P < 0.05)] and at 3 months [11.0% (8 of 73) versus 24.1% (19 of 79) (relative risk: 0.46, 95% confidence interval = 0.21, 0.98; P = 0.03)] compared with the single-dose arm.

Conclusions: The 7-day MTZ dose was more effective than the single dose for the treatment of TV among HIV+ women.

Trial registration: ClinicalTrials.gov NCT01018095.

Keywords: HIV-infected women; Trichomonas vaginalis; metronidazole.

Publication types

  • Clinical Trial, Phase IV
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adult
  • Antitrichomonal Agents / administration & dosage*
  • Antitrichomonal Agents / therapeutic use
  • CD4 Lymphocyte Count
  • CD4-Positive T-Lymphocytes / drug effects
  • Drug Administration Schedule
  • Female
  • HIV Infections / complications*
  • Humans
  • Metronidazole / administration & dosage*
  • Metronidazole / therapeutic use
  • Middle Aged
  • Sexual Partners
  • Trichomonas Infections / complications
  • Trichomonas Infections / drug therapy*
  • Trichomonas Infections / parasitology
  • Trichomonas Vaginitis / complications
  • Trichomonas Vaginitis / drug therapy*
  • Trichomonas Vaginitis / parasitology
  • Trichomonas vaginalis / drug effects*


  • Antitrichomonal Agents
  • Metronidazole

Associated data

  • ClinicalTrials.gov/NCT01018095