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Trichomonas Vaginalis Repeat Infections Among HIV Negative Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01832480
First Posted: April 16, 2013
Last Update Posted: August 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Patricia Kissinger, Tulane University Health Sciences Center
  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
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

Resource links provided by NLM:


Further study details as provided by Patricia Kissinger, 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 ]
    TV is assessed by nucleic acid amplification technique


Enrollment: 623
Actual Study Start Date: October 6, 2014
Study Completion Date: June 5, 2017
Primary Completion Date: June 5, 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=700). 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 BV at visit
  Contacts and Locations
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
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
Principal Investigator: Patricia Kissinger, MD Tulane Univeristy
  More Information

Publications:
Kissinger P, Amedee A, Clark RA, Dumestre J, Theall KP, Myers L, Hagensee ME, Farley TA, Martin DH. Trichomonas vaginalis treatment reduces vaginal HIV-1 shedding. Sex Transm Dis. 2009 Jan;36(1):11-6. doi: 10.1097/OLQ.0b013e318186decf.
Kissinger P, Secor WE, Leichliter JS, Clark RA, Schmidt N, Curtin E, Martin DH. Early repeated infections with Trichomonas vaginalis among HIV-positive and HIV-negative women. Clin Infect Dis. 2008 Apr 1;46(7):994-9. doi: 10.1086/529149.
Kissinger P, Schmidt N, Mohammed H, Leichliter JS, Gift TL, Meadors B, Sanders C, Farley TA. Patient-delivered partner treatment for Trichomonas vaginalis infection: a randomized controlled trial. Sex Transm Dis. 2006 Jul;33(7):445-50.
Kissinger P, Mena L, Levison J, Clark RA, Gatski M, Henderson H, Schmidt N, Rosenthal SL, Myers L, Martin DH. A randomized treatment trial: single versus 7-day dose of metronidazole for the treatment of Trichomonas vaginalis among HIV-infected women. J Acquir Immune Defic Syndr. 2010 Dec 15;55(5):565-71. doi: 10.1097/QAI.0b013e3181eda955.
Howe K, Kissinger PJ. Single-Dose Compared With Multidose Metronidazole for the Treatment of Trichomoniasis in Women: A Meta-Analysis. Sex Transm Dis. 2017 Jan;44(1):29-34.
Meites E, Gaydos CA, Hobbs MM, Kissinger P, Nyirjesy P, Schwebke JR, Secor WE, Sobel JD, Workowski KA. A Review of Evidence-Based Care of Symptomatic Trichomoniasis and Asymptomatic Trichomonas vaginalis Infections. Clin Infect Dis. 2015 Dec 15;61 Suppl 8:S837-48. doi: 10.1093/cid/civ738. Review.
Kissinger P. Trichomonas vaginalis: a review of epidemiologic, clinical and treatment issues. BMC Infect Dis. 2015 Aug 5;15:307. doi: 10.1186/s12879-015-1055-0. Review.

Responsible Party: Patricia Kissinger, Professor, Tulane University Health Sciences Center
ClinicalTrials.gov Identifier: NCT01832480     History of Changes
Other Study ID Numbers: 4042013
First Submitted: April 4, 2013
First Posted: April 16, 2013
Last Update Posted: August 4, 2017
Last Verified: August 2017
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:
Vaginitis
Trichomonas Infections
Trichomonas Vaginitis
Vaginal Diseases
Genital Diseases, Female
Protozoan Infections
Parasitic Diseases


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