Trichomonas Vaginalis Repeat Infections Among HIV Negative Women

NCT01832480 | Completed Phase 3 Results DMC

• 1 other identifier: 4042013
• Study Type: interventional
• Target: 623
• Locations: 1 country
• Sites: 3

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

Conditions

Vaginitis Trichomonal or Due to Trichomonas

Keywords

Trichomonas vaginalis; metronidazole

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

MTZ 2 g

ACTIVE COMPARATOR

Single dose MTZ

Drug: MTZ 2 g

MTZ 500 mg twice daily x 7 days

EXPERIMENTAL

Multi dose MTZ

Drug: MTZ 500 mg twice daily x 7 days

Interventions

MTZ 500 mg twice daily x 7 days DRUG

MTZ 500 mg twice daily x 7 days

Also known as: Multi-dose MTZ

MTZ 500 mg twice daily x 7 days

MTZ 2 g DRUG

MTZ 2 g

Also known as: Single dose MTZ

MTZ 2 g

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female
• English speaking
• \>= 18 years old

You may not qualify if:

• HIV-infected
• unable to provide informed consent
• pregnant
• breast feeding
• treated by their provider for Bacterial vaginosis (BV) at visit

Sponsors & Collaborators

• Tulane University Health Sciences Center: lead

Study Sites (3)

Jefferson County Dept of Health/STD Specialty Clinic

Birmingham, Alabama, 35233, United States

Location

CrescentCare Health and Wellness Center

New Orleans, Louisiana, 70119, United States

Location

Crossroads Clinic

Jackson, Mississippi, 39213, United States

Location

Related Publications (7)

• 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.

  PMID: 19008776 BACKGROUND

• 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.

  PMID: 18444815 BACKGROUND

• 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. doi: 10.1097/01.olq.0000204511.84485.4c.

  PMID: 16531939 BACKGROUND

• 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.

  PMID: 21423852 BACKGROUND

• 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. doi: 10.1097/OLQ.0000000000000537.

  PMID: 27898571 BACKGROUND

• 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(Suppl 8):S837-48. doi: 10.1093/cid/civ738.

  PMID: 26602621 BACKGROUND

• 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.

  PMID: 26242185 BACKGROUND

MeSH Terms

Conditions

Trichomonas Vaginitis

Condition Hierarchy (Ancestors)

Trichomonas Infections; Protozoan Infections; Parasitic Diseases; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Patricia Kissinger, Ph.D.
• Organization: Tulane University School of Public Health and Tropical Medicine

kissing@tulane.edu

504-988-7320

Study Officials

• Patricia Kissinger, MD

  Tulane Univeristy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This was an open label study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 4, 2013
• First Posted: April 16, 2013
• Study Start: October 6, 2014
• Primary Completion: June 5, 2017
• Study Completion: June 5, 2017
• Last Updated: February 12, 2019
• Results First Posted: February 12, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)