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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
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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.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5  

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

Other Adverse Events
    Nitazoxanide With Pegylated Interferon And Ribavirin
Total, other (not including serious) adverse events   
# participants affected / at risk   8/8 (100.00%) 
Blood and lymphatic system disorders   
Lymphadenopathy   
# participants affected / at risk   1/8 (12.50%) 
# events   1 
Gastrointestinal disorders   
Diarrhoea   
# participants affected / at risk   1/8 (12.50%) 
# events   9 
Flatulence   
# participants affected / at risk   1/8 (12.50%) 
# events   2 
Nausea   
# participants affected / at risk   2/8 (25.00%) 
# events   3 
Vomiting   
# participants affected / at risk   1/8 (12.50%) 
# events   3 
Constipation   
# participants affected / at risk   1/8 (12.50%) 
# events   2 
Abdominal pain   
# participants affected / at risk   1/8 (12.50%) 
# events   3 
Dysphagia   
# participants affected / at risk   1/8 (12.50%) 
# events   1 
Gastrooesophageal reflux disease   
# participants affected / at risk   1/8 (12.50%) 
# events   1 
General disorders   
Fatigue   
# participants affected / at risk   1/8 (12.50%) 
# events   3 
Chills   
# participants affected / at risk   1/8 (12.50%) 
# events   1 
Hepatobiliary disorders   
Hyperbilirubinaemia   
# participants affected / at risk   1/8 (12.50%) 
# events   3 
Infections and infestations   
Abscess oral   
# participants affected / at risk   1/8 (12.50%) 
# events   1 
Acute sinusitis   
# participants affected / at risk   1/8 (12.50%) 
# events   1 
Investigations   
Alanine aminotransferase increased   
# participants affected / at risk   1/8 (12.50%) 
# events   9 
Aspartate aminotransferase increased   
# participants affected / at risk   1/8 (12.50%) 
# events   14 
Blood glucose increased   
# participants affected / at risk   1/8 (12.50%) 
# events   1 
Blood creatinine increased   
# participants affected / at risk   1/8 (12.50%) 
# events   1 
Blood albumin decreased   
# participants affected / at risk   1/8 (12.50%) 
# events   8 
Blood potassium increased   
# participants affected / at risk   1/8 (12.50%) 
# events   1 
Blood calcium decreased   
# participants affected / at risk   1/8 (12.50%) 
# events   2 
Blood potassium decreased   
# participants affected / at risk   1/8 (12.50%) 
# events   1 
Neutrophil count decreased   
# participants affected / at risk   2/8 (25.00%) 
# events   10 
Platelet count decreased   
# participants affected / at risk   1/8 (12.50%) 
# events   7 
Serum albumin decreased   
# participants affected / at risk   1/8 (12.50%) 
# events   1 
White blood cell count decreased   
# participants affected / at risk   3/8 (37.50%) 
# events   5 
Musculoskeletal and connective tissue disorders   
Back pain   
# participants affected / at risk   1/8 (12.50%) 
# events   1 
Myalgia   
# participants affected / at risk   1/8 (12.50%) 
# events   1 
Nervous system disorders   
Headache   
# participants affected / at risk   1/8 (12.50%) 
# events   3 
Dysgeusia   
# participants affected / at risk   1/8 (12.50%) 
# events   1 
Renal and urinary disorders   
Chromaturia   
# participants affected / at risk   1/8 (12.50%) 
# events   2 
Skin and subcutaneous tissue disorders   
Dermal cyst   
# participants affected / at risk   1/8 (12.50%) 
# events   1 
1 Term from vocabulary, MedDRA (Unspecified)



  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