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Trichomonas Vaginalis Recurrence Among HIV+ Women

This study has been completed.
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:
Tulane University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT01018095
First received: November 20, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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 among HIV-infected women.


Condition Intervention Phase
Trichomonas Infections
HIV Infections
 Drug: Metronidazole
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Randomized Phase IV Trial of Metronidazole Single Dose Versus 7 Day Dose for Treatment of Trichomonas Vaginalis Among HIV-infected Women

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Tulane University Health Sciences Center:

Primary Outcome Measures:
  • TV culture results [ Time Frame: test-of-cure visit at 6-12 days post-treatment completion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • TV culture results [ Time Frame: 3 months and 6 months post-enrollment ] [ Designated as safety issue: No ]

Enrollment: 270
Study Start Date: May 2005
Study Completion Date: August 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Single dose Drug: Metronidazole
2 gm single dose versus 7 day 500 mg BID dose
Other Name: Flagyl
Active Comparator: 7 day dose Drug: Metronidazole
2 gm single dose versus 7 day 500 mg BID dose
Other Name: Flagyl

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01018095

Locations
United States, Louisiana
HIV Outpatient Clinic
New Orleans, Louisiana, United States, 70112
NOAIDS
New Orleans, Louisiana, United States, 70119
United States, Mississippi
Crossroads Clinic
Jackson, Mississippi, United States, 39216
United States, Texas
Thomas St Clinic
Houston, Texas, United States, 77009
Northwest Clinic
Houston, Texas, United States, 77040
Sponsors and Collaborators
Tulane University Health Sciences Center
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Patricia Kissinger, Ph.D. Tulane University
  More Information

No publications provided by Tulane University Health Sciences Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Patricia Kissinger, Ph.D., Tulane University, Department of Epidemiology
ClinicalTrials.gov Identifier: NCT01018095     History of Changes
Other Study ID Numbers: 543793, U19AI061972
Study First Received: November 20, 2009
Last Updated: November 20, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Trichomonas Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
 Slow Virus Diseases
Protozoan Infections
Parasitic Diseases
Metronidazole
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on May 19, 2013