Trichomonas Vaginalis Repeat Infections Among HIV Negative Women

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Patricia Kissinger, Tulane University Health Sciences Center Identifier:
First received: April 4, 2013
Last updated: August 19, 2014
Last verified: August 2014

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

Condition Intervention Phase
Vaginitis Trichomonal or Due to Trichomonas
Drug: MTZ 250 mg BID
Drug: MTZ 2 g
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Trichomonas Vaginalis Repeat Infections Among HIV Negative Women

Resource links provided by NLM:

Further study details as provided by Tulane University Health Sciences Center:

Primary Outcome Measures:
  • TV negative after treatment with either multi or single dose MTZ [ Time Frame: 1 month post treatment completion ] [ Designated as safety issue: No ]

Estimated Enrollment: 1664
Study Start Date: June 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MTZ 2 g
Single dose MTZ
Drug: MTZ 2 g
MTZ 2 g
Other Name: Single dose MTZ
Experimental: MTZ 250 mg BID
Multi dose MTZ
Drug: MTZ 250 mg BID
MTZ 250 mg BID
Other Name: Multi-dose

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=1664). Subjects will undergo an audio computer assisted self- interview (ACASI), and will self-collect a vaginal swab for Gram stain testing and be randomized into one of two arms; metronidazole (MTZ) 2 g single dose (CDC recommended treatment regimen) or MTZ 500 mg BID 7-day dose (CDC alternative treatment regimen). All enrolled women will be asked to return for a follow-up visit at one month after baseline (window 3-13 weeks).


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • female
  • English speaking
  • >= 18 years old (Crossroads, Delgado, ILH LSU OB/GYN); >=19 years old (JCDH)

Exclusion Criteria:

  • HIV-infected
  • unable to provide informed consent
  • pregnant
  • breast feeding
  • treated by their provider for BV (by Amsel criteria) at visit
  Contacts and Locations
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Please refer to this study by its identifier: NCT01832480

United States, Alabama
Jefferson County Dept of Health/STD Specialty Clinic
Birmingham, Alabama, United States, 35233
United States, Louisiana
Delgado Personal Health Center
New Orleans, Louisiana, United States, 70112
New Orleans, Louisiana, United States, 70112
United States, Mississippi
Crossroads Clinic
Jackson, Mississippi, United States, 39213
Sponsors and Collaborators
Tulane University Health Sciences Center
Principal Investigator: Patricia Kissinger, MD Tulane Univeristy
  More Information

Responsible Party: Patricia Kissinger, Professor, Tulane University Health Sciences Center Identifier: NCT01832480     History of Changes
Other Study ID Numbers: 4042013
Study First Received: April 4, 2013
Last Updated: August 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Tulane University Health Sciences Center:
Trichomonas vaginalis

Additional relevant MeSH terms:
Trichomonas Infections
Trichomonas Vaginitis
Protozoan Infections
Parasitic Diseases
Vaginal Diseases
Genital Diseases, Female processed this record on October 19, 2014