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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
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
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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
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

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  
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 ]

Measure Type Primary
Measure Title Number of Participants With Adverse Events
Measure Description Adverse events determined and evaluated by patient reporting and the DAIDS toxicity table.
Time Frame 2 years  
Safety Issue Yes  

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  
Number of Participants Analyzed  
[units: participants]
  8  
Number of Participants With Adverse Events  
[units: adverse¬†events]
  8  

No statistical analysis provided for Number of Participants With Adverse Events



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

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  
Safety Issue No  

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  
Number of 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.   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
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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
Health Authority: United States: Federal Government