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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
History of Changes
Results First Received: 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.
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 
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 ]
  Show Outcome Measure 1

2.  Secondary:   Sustained Viral Response Rate   [ Time Frame: 72 weeks ]
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Measure Type Secondary
Measure Title Sustained Viral Response Rate
Measure Description Proportion of participants that are HCV negative 6 months after treatment completion
Time Frame 72 weeks  

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

Measured Values
   Nitazoxanide With Pegylated Interferon And Ribavirin 
Participants Analyzed 
[Units: Participants]
 		 8 
Sustained Viral Response Rate 
[Units: Participants]
 		 8 

No statistical analysis provided for Sustained Viral Response Rate



3.  Secondary:   Tolerability   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events
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  Other Adverse Events
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  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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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Shyam Kottilil
Organization: NIAID/NIH
phone: 301-435-0936
e-mail: skottilil@niaid.nih.gov


Publications:


Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01185028     History of Changes
Other Study ID Numbers: 100183
10-CC-0183
Study First Received: August 18, 2010
Results First Received: March 21, 2013
Last Updated: May 16, 2013