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Trichomonas Vaginalis Recurrence Among HIV+ Women

Primary Purpose

Trichomonas Infections, HIV Infections

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Metronidazole
Sponsored by
Tulane University Health Sciences Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trichomonas Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • HIV Outpatient Clinic
  • NOAIDS
  • Crossroads Clinic
  • Thomas St Clinic
  • Northwest Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Single dose

7 day dose

Arm Description

Metronidazole 2 gm single dose

Metronidazole 500 mg dose x 7 days

Outcomes

Primary Outcome Measures

TV Culture Positive Result
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
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.

Full Information

First Posted
November 20, 2009
Last Updated
December 16, 2016
Sponsor
Tulane University Health Sciences Center
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT01018095
Brief Title
Trichomonas Vaginalis Recurrence Among HIV+ Women
Official Title
Randomized Phase IV Trial of Metronidazole Single Dose Versus 7 Day Dose for Treatment of Trichomonas Vaginalis Among HIV-infected Women
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tulane University Health Sciences Center
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trichomonas Infections, HIV Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single dose
Arm Type
Active Comparator
Arm Description
Metronidazole 2 gm single dose
Arm Title
7 day dose
Arm Type
Active Comparator
Arm Description
Metronidazole 500 mg dose x 7 days
Intervention Type
Drug
Intervention Name(s)
Metronidazole
Other Intervention Name(s)
Flagyl
Intervention Description
2 gm single dose versus 7 day 500 mg BID dose
Primary Outcome Measure Information:
Title
TV Culture Positive Result
Description
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.
Time Frame
test-of-cure visit at 6-12 days post-treatment completion
Secondary Outcome Measure Information:
Title
TV Culture Positive Result
Description
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.
Time Frame
3 months post-enrollment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Kissinger, Ph.D.
Organizational Affiliation
Tulane University
Official's Role
Principal Investigator
Facility Information:
Facility Name
HIV Outpatient Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
NOAIDS
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States
Facility Name
Crossroads Clinic
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Thomas St Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77009
Country
United States
Facility Name
Northwest Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77040
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30297322
Citation
Kissinger P, Muzny CA, Mena LA, Lillis RA, Schwebke JR, Beauchamps L, Taylor SN, Schmidt N, Myers L, Augostini P, Secor WE, Bradic M, Carlton JM, Martin DH. Single-dose versus 7-day-dose metronidazole for the treatment of trichomoniasis in women: an open-label, randomised controlled trial. Lancet Infect Dis. 2018 Nov;18(11):1251-1259. doi: 10.1016/S1473-3099(18)30423-7. Epub 2018 Oct 5.
Results Reference
derived
PubMed Identifier
21423852
Citation
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.
Results Reference
derived

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Trichomonas Vaginalis Recurrence Among HIV+ Women

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