Trichomonas Vaginalis Repeat Infections Among HIV Negative Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Tulane University Health Sciences Center
Information provided by (Responsible Party):
Patricia Kissinger, Tulane University Health Sciences Center Identifier:
First received: April 4, 2013
Last updated: May 19, 2016
Last verified: May 2016
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 500 mg BID x 7 days
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: 4 weeks 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 500 mg BID x 7 days
Multi dose MTZ
Drug: MTZ 500 mg BID x 7 days
MTZ 500 mg BID x 7days
Other Name: Multi-dose MTZ

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 vaginal swabs for Trichomonas testing by InPouch and 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 BID 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).

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

Exclusion Criteria:

  • HIV-infected
  • unable to provide informed consent
  • pregnant
  • breast feeding
  • treated by their provider for BV at visit
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01832480

Contact: Patricia Kissinger, PhD

United States, Alabama
Jefferson County Dept of Health/STD Specialty Clinic Recruiting
Birmingham, Alabama, United States, 35233
Contact: Christina Muzny, MD    205-975-3298   
Principal Investigator: Christina Muzny, MD         
Sub-Investigator: Jane Schwebke, MD         
United States, Louisiana
CrescentCare Health and Wellness Center Recruiting
New Orleans, Louisiana, United States, 70119
Contact: Stephanie N Taylor, MD   
Principal Investigator: Stephanie N Taylor, MD         
Sub-Investigator: Rebecca Lillis, MD         
Sub-Investigator: David Martin, MD         
United States, Mississippi
Crossroads Clinic Recruiting
Jackson, Mississippi, United States, 39213
Contact: Leandro Mena, MD    601-937-2387   
Principal Investigator: Leandro Mena, MD         
Sub-Investigator: Laura Beauchamps, MD         
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: May 19, 2016
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
Genital Diseases, Female
Parasitic Diseases
Protozoan Infections
Vaginal Diseases
Vaginitis processed this record on May 26, 2016