Trichomonas Vaginalis Repeat Infections Among HIV Negative Women

Vaginitis Trichomonal or Due to Trichomonas Clinical Trial

Official title:

Trichomonas Vaginalis Repeat Infections Among HIV Negative Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01832480
• Other study ID #: 4042013
• Status: Completed
• Phase: Phase 3
• Start date: October 6, 2014
• Est. completion date: June 5, 2017

Study information

• Verified date: January 2019
• Source: Tulane University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 623
• Est. completion date: June 5, 2017
• Est. primary completion date: June 5, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Trichomonas Infections
• Trichomonas Vaginitis
• Vaginitis
• Vaginitis Trichomonal or Due to Trichomonas

Intervention

Drug:
• MTZ 500 mg twice daily x 7 days
MTZ 500 mg twice daily x 7 days
• MTZ 2 g
MTZ 2 g

Locations

Country	Name	City	State
United States	Jefferson County Dept of Health/STD Specialty Clinic	Birmingham	Alabama
United States	Crossroads Clinic	Jackson	Mississippi
United States	CrescentCare Health and Wellness Center	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Tulane University Health Sciences Center

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects That Were Trichomonas Vaginalis (TV) Positive After Treatment With Metronidazole (MTZ)	Presence of TV is assessed by nucleic acid amplification test (NAAT) of vaginal swab collected 4 weeks post treatment completion.	4 weeks post treatment completion