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Trichomonas Vaginalis Repeat Infections Among HIV Negative Women

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ClinicalTrials.gov Identifier: NCT01832480
Recruitment Status : Completed
First Posted : April 16, 2013
Results First Posted : February 12, 2019
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Patricia Kissinger, Tulane University Health Sciences Center

Brief 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

Condition or disease Intervention/treatment Phase
Vaginitis Trichomonal or Due to Trichomonas Drug: MTZ 500 mg twice daily x 7 days Drug: MTZ 2 g Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 623 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: This was an open label study
Primary Purpose: Treatment
Official Title: Trichomonas Vaginalis Repeat Infections Among HIV Negative Women
Actual Study Start Date : October 6, 2014
Actual Primary Completion Date : June 5, 2017
Actual Study Completion Date : June 5, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: MTZ 2 g
Single dose MTZ
Drug: MTZ 2 g
MTZ 2 g
Other Name: Single dose MTZ

Experimental: MTZ 500 mg twice daily x 7 days
Multi dose MTZ
Drug: MTZ 500 mg twice daily x 7 days
MTZ 500 mg twice daily x 7 days
Other Name: Multi-dose MTZ




Primary Outcome Measures :
  1. Number of Subjects That Were Trichomonas Vaginalis (TV) Positive After Treatment With Metronidazole (MTZ) [ Time Frame: 4 weeks post treatment completion ]
    Presence of TV is assessed by nucleic acid amplification test (NAAT) of vaginal swab collected 4 weeks post treatment completion.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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 Bacterial vaginosis (BV) at visit

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01832480


Locations
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United States, Alabama
Jefferson County Dept of Health/STD Specialty Clinic
Birmingham, Alabama, United States, 35233
United States, Louisiana
CrescentCare Health and Wellness Center
New Orleans, Louisiana, United States, 70119
United States, Mississippi
Crossroads Clinic
Jackson, Mississippi, United States, 39213
Sponsors and Collaborators
Tulane University Health Sciences Center
Investigators
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Principal Investigator: Patricia Kissinger, MD Tulane Univeristy
  Study Documents (Full-Text)

Documents provided by Patricia Kissinger, Tulane University Health Sciences Center:

Publications:

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Responsible Party: Patricia Kissinger, Professor, Tulane University Health Sciences Center
ClinicalTrials.gov Identifier: NCT01832480     History of Changes
Other Study ID Numbers: 4042013
First Posted: April 16, 2013    Key Record Dates
Results First Posted: February 12, 2019
Last Update Posted: February 12, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Patricia Kissinger, Tulane University Health Sciences Center:
Trichomonas vaginalis
metronidazole
Additional relevant MeSH terms:
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Trichomonas Infections
Trichomonas Vaginitis
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Protozoan Infections
Parasitic Diseases