Trichomonas Vaginalis Repeat Infections Among HIV Negative Women

Tulane University Health Sciences Center

Status and phase: Completed; Phase 3

Conditions: Vaginitis Trichomonal or Due to Trichomonas

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01832480

4042013

Details and patient eligibility

About

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

Full 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).

Enrollment: 623 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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623 participants in 2 patient groups

MTZ 2 g

Active Comparator group

Description:

Single dose MTZ

Treatment:

Drug: MTZ 2 g

MTZ 500 mg twice daily x 7 days

Experimental group

Description:

Multi dose MTZ

Treatment:

Drug: MTZ 500 mg twice daily x 7 days