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Trichomonas Vaginalis Recurrence Among HIV+ Women

Information source: Tulane University Health Sciences Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Trichomonas Infections; HIV Infections

Intervention: Metronidazole (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Tulane University Health Sciences Center

Official(s) and/or principal investigator(s):
Patricia Kissinger, Ph.D., Principal Investigator, Affiliation: Tulane University


The purpose of this study is to determine if the 2 gram single dose of metronidazole is as effective as the 7 day 500 mg BID dose for treatment of Trichomonas vaginalis (TV) among HIV-infected women.

Clinical Details

Official title: Randomized Phase IV Trial of Metronidazole Single Dose Versus 7 Day Dose for Treatment of Trichomonas Vaginalis Among HIV-infected Women

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: TV Culture Positive Result

Secondary outcome: TV Culture Positive Result

Detailed description: This is a Phase IV equivalency trial as both doses of metronidazole are listed in the the Centers for Disease Control and Prevention Treatment Guidelines for the treatment of T vaginalis.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.


Inclusion Criteria:

- Female

- 18 years or older

- HIV-positive

- TV positive by either wet preparation or culture

- ability to refrain from all alcohol use for 24 hours before and after taking oral


- willing to take metronidazole treatment

Exclusion Criteria:

- pregnant

- incarcerated

- previously enrolled

- currently taking disulfiram

- alcoholism or known liver damage

- medical contraindications to metronidazole

- treated with metronidazole within the previous 14 days

- requires treatment for B. V. per Amsel's criteria

Locations and Contacts

HIV Outpatient Clinic, New Orleans, Louisiana 70112, United States

NOAIDS, New Orleans, Louisiana 70119, United States

Crossroads Clinic, Jackson, Mississippi 39216, United States

Northwest Clinic, Houston, Texas 77040, United States

Thomas St Clinic, Houston, Texas 77009, United States

Additional Information

Starting date: May 2005
Last updated: July 15, 2013

Page last updated: August 23, 2015

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