Trichomonas Vaginalis Repeat Infections Among HIV Negative Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Tulane University Health Sciences Center
Sponsor:
Information provided by (Responsible Party):
Patricia Kissinger, Tulane University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT01832480
First received: April 4, 2013
Last updated: July 28, 2016
Last verified: July 2016
  Purpose
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).
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01832480

Contacts
Contact: Patricia Kissinger, PhD kissing@tulane.edu

Locations
United States, Alabama
Jefferson County Dept of Health/STD Specialty Clinic Recruiting
Birmingham, Alabama, United States, 35233
Contact: Christina Muzny, MD    205-975-3298    cmuzny@uab.edu   
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: Rebecca Lillis, MD       rlilli@lsuhsc.edu   
Sub-Investigator: Stephanie N Taylor, MD         
Principal Investigator: Rebecca Lillis, MD         
United States, Mississippi
Crossroads Clinic Active, not recruiting
Jackson, Mississippi, United States, 39213
Sponsors and Collaborators
Tulane University Health Sciences Center
Investigators
Principal Investigator: Patricia Kissinger, MD Tulane Univeristy
  More Information

Publications:
Responsible Party: Patricia Kissinger, Professor, Tulane University Health Sciences Center
ClinicalTrials.gov Identifier: NCT01832480     History of Changes
Other Study ID Numbers: 4042013 
Study First Received: April 4, 2013
Last Updated: July 28, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Tulane University Health Sciences Center:
Trichomonas vaginalis
metronidazole

Additional relevant MeSH terms:
Vaginitis
Trichomonas Infections
Trichomonas Vaginitis
Vaginal Diseases
Genital Diseases, Female
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on August 23, 2016