A Safety and Tolerability Study of Nitazoxanide in HIV-HCV Treatment Failures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01185028
First received: August 18, 2010
Last updated: May 16, 2013
Last verified: May 2013
Results First Received: March 21, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hepatitis C Infection
HIV Infection
Intervention: Drug: Nitazoxanide With Pegylated Interferon And Ribavirin

  Participant Flow


  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
Nitazoxanide With Pegylated Interferon And Ribavirin Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks

Baseline Measures
    Nitazoxanide With Pegylated Interferon And Ribavirin  
Number of Participants  
[units: participants]
  8  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     7  
>=65 years     1  
Age [1]
[units: years]
Mean ± Standard Deviation
  56.375  ± 7.4487834577198  
Gender  
[units: participants]
 
Female     2  
Male     6  
Region of Enrollment  
[units: participants]
 
United States     8  
[1] Mean has been calculated to the third decimal place. Standard Deviation value has been calculated to the thirteenth decimal place



  Outcome Measures
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1.  Primary:   Number of Participants With Adverse Events   [ Time Frame: 2 years ]

2.  Secondary:   Sustained Viral Response Rate   [ Time Frame: 72 weeks ]

3.  Secondary:   Tolerability   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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
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  More Information