NCT01832480

Trichomonas Vaginalis Repeat Infections Among HIV Negative Women

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 623 (actual)
• Sponsor: Tulane University Health Sciences Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overall goal of this project is to determine the influence of patient treatment and host factors on repeat Trichomonas vaginalis (TV) infections among HIV-negative women

Detailed description

This study is a phase III randomized clinical trial. HIV-negative women who test positive for TV at their routine gynecological exam at participating clinics will be referred to the nurse/study coordinator to screen for eligibility, provide a description of the study, and obtain written, informed consent (N=700). Subjects will undergo an audio computer assisted self- interview (ACASI), and will self-collect vaginal swabs for Trichomonas testing by InPouch and Nucleic Acid Amplification Test (NAAT), Gram stain testing, and a future microbiome specimen. They will be randomized into one of two arms; metronidazole (MTZ) 2 g single dose (CDC recommended treatment regimen) or MTZ 500 mg twice daily x 7-day dose (CDC alternative treatment regimen). All enrolled women will be scheduled for a follow-up visit at four weeks post treatment completion (window 3-13 weeks).

Conditions

• Vaginitis Trichomonal or Due to Trichomonas

Interventions

Type	Name	Description
DRUG	MTZ 500 mg twice daily x 7 days	MTZ 500 mg twice daily x 7 days
DRUG	MTZ 2 g	MTZ 2 g

Timeline

• Start date: 2014-10-06
• Primary completion: 2017-06-05
• Completion: 2017-06-05
• First posted: 2013-04-16
• Last updated: 2019-02-12
• Results posted: 2019-02-12

Locations

3 sites across 1 country: United States