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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01185028
First Posted: August 19, 2010
Last Update Posted: May 27, 2013
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.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)
Results First Submitted: March 21, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Hepatitis C Infection
HIV Infection
Intervention: Drug: Nitazoxanide With Pegylated Interferon And Ribavirin

  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
No text entered.

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

Participant Flow:   Overall Study
    Nitazoxanide With Pegylated Interferon And Ribavirin
STARTED   8 
COMPLETED   4 
NOT COMPLETED   4 



  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.
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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 
Overall Participants Analyzed 
[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) 
[1] Mean has been calculated to the third decimal place. Standard Deviation value has been calculated to the thirteenth decimal place
Gender 
[Units: Participants]
 
Female   2 
Male   6 
Region of Enrollment 
[Units: Participants]
 
United States   8 


  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 reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events
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Time Frame No text entered.
Additional Description 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

Serious Adverse Events
    Nitazoxanide With Pegylated Interferon And Ribavirin
Total, Serious Adverse Events   
# participants affected / at risk   0/8 (0.00%) 




  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



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