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
Results First Received: April 11, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Conditions: Trichomonas Infections
HIV Infections
Intervention: Drug: Metronidazole

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
HIV-infected women undergoing a routine gynecological examination performed by a clinic health care provider between May 1, 2006 and July 17, 2009 were tested for Trichomonas Vaginalis (TV) by culture as standard of care practice in selected public HIV outpatient clinics in New Orleans, Louisiana; Houston, Texas; and Jackson, Mississippi.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
N/A

Reporting Groups
  Description
7 Day Dose Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
Single Dose Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose

Participant Flow:   Overall Study
    7 Day Dose     Single Dose  
STARTED     135     135  
COMPLETED     79     73  
NOT COMPLETED     56     62  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
7 Day Dose Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
Single Dose Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
Total Total of all reporting groups

Baseline Measures
    7 Day Dose     Single Dose     Total  
Number of Participants  
[units: participants]
  135     135     270  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     135     134     269  
>=65 years     0     1     1  
Age  
[units: years]
Mean ± Standard Deviation
  39.5  ± 9.3     40.7  ± 9.4     40.1  ± 9.4  
Gender  
[units: participants]
     
Female     135     135     270  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     135     135     270  



  Outcome Measures
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1.  Primary:   TV Culture Positive Result   [ Time Frame: test-of-cure visit at 6-12 days post-treatment completion ]

2.  Secondary:   TV Culture Positive Result   [ Time Frame: 3 months post-enrollment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Generalizability is always a concern in clinical trials, however our findings are likely generalizable to the majority of HIV-infected women in the U.S. though studies in Caucasian and Hispanic women are needed.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Patricia Kissinger, PhD
Organization: Tulane University
phone: 5049887320
e-mail: kissing@tulane.edu


No publications provided by Tulane University Health Sciences Center

Publications automatically indexed to this study:

Responsible Party: Patricia Kissinger, 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