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

History of Changes

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:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

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:

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.


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 September 23, 2016

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