Trichomonas Vaginalis Recurrence Among HIV+ Women

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Patricia Kissinger, Tulane University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT01018095
First received: November 20, 2009
Last updated: July 15, 2013
Last verified: July 2013
  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 (TV) 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:


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

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


Secondary Outcome Measures:
  • TV Culture Positive Result [ Time Frame: 3 months post-enrollment ] [ Designated as safety issue: No ]
    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.


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
Metronidazole 2 gm single dose
Drug: Metronidazole
2 gm single dose versus 7 day 500 mg BID dose
Other Name: 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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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, Principal Investigator, Tulane University Health Sciences Center
ClinicalTrials.gov Identifier: NCT01018095     History of Changes
Other Study ID Numbers: 543793, U19AI061972
Study First Received: November 20, 2009
Results First Received: April 11, 2013
Last Updated: July 15, 2013
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 July 24, 2014