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
Summary
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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
metronidazole
- 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
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