Trichomonas Vaginalis Recurrence Among HIV+ Women

December 16, 2016 updated by: Patricia Kissinger, Tulane University Health Sciences Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

270

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • HIV Outpatient Clinic
      • New Orleans, Louisiana, United States, 70119
        • NOAIDS
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Crossroads Clinic
    • Texas
      • Houston, Texas, United States, 77009
        • Thomas St Clinic
      • Houston, Texas, United States, 77040
        • Northwest Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Single dose
Metronidazole 2 gm single dose
Drug: Metronidazole
2 gm single dose versus 7 day 500 mg BID dose
Other Names:
  • Flagyl
Active Comparator: 7 day dose
Metronidazole 500 mg dose x 7 days
Drug: Metronidazole
2 gm single dose versus 7 day 500 mg BID dose
Other Names:
  • Flagyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TV Culture Positive Result
Time Frame: test-of-cure visit at 6-12 days post-treatment completion
At the participants' test of cure (TOC) visits they were screened for Trichomonas vaginalis using (InPouch) culture. Presence of parasite will yield a culture positive result.
test-of-cure visit at 6-12 days post-treatment completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TV Culture Positive Result
Time Frame: 3 months post-enrollment
Participants who returned for their follow up visits were tested for Trichomonas vaginalis using InPouch culture. If parasites are present, it will yield a culture positive result.
3 months post-enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tulane University Health Sciences Center

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Principal Investigator: Patricia Kissinger, Ph.D., Tulane University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

November 20, 2009

First Submitted That Met QC Criteria

November 20, 2009

First Posted (Estimate)

November 23, 2009

Study Record Updates

Last Update Posted (Estimate)

December 20, 2016

Last Update Submitted That Met QC Criteria

December 16, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 543793
  • U19AI061972 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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