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Trichomonas Vaginalis Recurrence Among HIV+ Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01018095
First Posted: November 23, 2009
Last Update Posted: December 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Patricia Kissinger, Tulane University Health Sciences Center
November 20, 2009
November 23, 2009
April 11, 2013
July 15, 2013
December 20, 2016
May 2005
July 2009   (Final data collection date for primary outcome measure)
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.
TV culture results [ Time Frame: test-of-cure visit at 6-12 days post-treatment completion ]
Complete list of historical versions of study NCT01018095 on ClinicalTrials.gov Archive Site
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.
TV culture results [ Time Frame: 3 months and 6 months post-enrollment ]
Not Provided
Not Provided
 
Trichomonas Vaginalis Recurrence Among HIV+ Women
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
  • Trichomonas Infections
  • HIV Infections
Drug: Metronidazole
2 gm single dose versus 7 day 500 mg BID dose
Other Name: Flagyl
  • Active Comparator: Single dose
    Metronidazole 2 gm single dose
    Intervention: Drug: Metronidazole
  • Active Comparator: 7 day dose
    Metronidazole 500 mg dose x 7 days
    Intervention: Drug: Metronidazole
Kissinger P, Mena L, Levison J, Clark RA, Gatski M, Henderson H, Schmidt N, Rosenthal SL, Myers L, Martin DH. A randomized treatment trial: single versus 7-day dose of metronidazole for the treatment of Trichomonas vaginalis among HIV-infected women. J Acquir Immune Defic Syndr. 2010 Dec 15;55(5):565-71. doi: 10.1097/QAI.0b013e3181eda955.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
270
August 2009
July 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01018095
543793
U19AI061972 ( U.S. NIH Grant/Contract )
No
Not Provided
Plan to Share IPD: No
Patricia Kissinger, Tulane University Health Sciences Center
Tulane University Health Sciences Center
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Patricia Kissinger, Ph.D. Tulane University
Tulane University
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP