Trichomonas Vaginalis Repeat Infections Among HIV Negative Women

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ClinicalTrials.gov Identifier: NCT01832480

Recruitment Status : Completed

First Posted : April 16, 2013

Last Update Posted : August 4, 2017

Sponsor:

Information provided by (Responsible Party):

Patricia Kissinger, Tulane University Health Sciences Center

Study Description

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 BID 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 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).

Study Design


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

U.S. FDA Resources

Arms and Interventions

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 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

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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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. Review.

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 Posted:	April 16, 2013 Key Record Dates
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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