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

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ClinicalTrials.gov Identifier: NCT01185028
Recruitment Status : Completed
First Posted : August 19, 2010
Results First Posted : May 15, 2013
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)

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
Enrollment 8
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Nitazoxanide With Pegylated Interferon And Ribavirin
Hide Arm/Group Description Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks
Period Title: Overall Study
Started 8
Completed 4
Not Completed 4
Arm/Group Title Nitazoxanide With Pegylated Interferon And Ribavirin
Hide Arm/Group Description Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks
Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
0
   0.0%
Between 18 and 65 years
7
  87.5%
>=65 years
1
  12.5%
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants
56.375  (7.4487834577198)
[1]
Measure Description: Mean has been calculated to the third decimal place. Standard Deviation value has been calculated to the thirteenth decimal place
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
2
  25.0%
Male
6
  75.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants
8
1.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description Adverse events determined and evaluated by patient reporting and the DAIDS toxicity table.
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nitazoxanide With Pegylated Interferon And Ribavirin
Hide Arm/Group Description:
Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: adverse events
8
2.Secondary Outcome
Title Sustained Viral Response Rate
Hide Description Proportion of participants that are HCV negative 6 months after treatment completion
Time Frame 72 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nitazoxanide With Pegylated Interferon And Ribavirin
Hide Arm/Group Description:
Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: participants
8
3.Secondary Outcome
Title Tolerability
Hide Description Proportion of individuals that discontinued study drug
Time Frame 2 years
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nitazoxanide With Pegylated Interferon And Ribavirin
Hide Arm/Group Description Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks
All-Cause Mortality
Nitazoxanide With Pegylated Interferon And Ribavirin
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Nitazoxanide With Pegylated Interferon And Ribavirin
Affected / at Risk (%) # Events
Total   0/8 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Nitazoxanide With Pegylated Interferon And Ribavirin
Affected / at Risk (%) # Events
Total   8/8 (100.00%)    
Blood and lymphatic system disorders   
Lymphadenopathy  1/8 (12.50%)  1
Gastrointestinal disorders   
Diarrhoea  1/8 (12.50%)  9
Flatulence  1/8 (12.50%)  2
Nausea  2/8 (25.00%)  3
Vomiting  1/8 (12.50%)  3
Constipation  1/8 (12.50%)  2
Abdominal pain  1/8 (12.50%)  3
Dysphagia  1/8 (12.50%)  1
Gastrooesophageal reflux disease  1/8 (12.50%)  1
General disorders   
Fatigue  1/8 (12.50%)  3
Chills  1/8 (12.50%)  1
Hepatobiliary disorders   
Hyperbilirubinaemia  1/8 (12.50%)  3
Infections and infestations   
Abscess oral  1/8 (12.50%)  1
Acute sinusitis  1/8 (12.50%)  1
Investigations   
Alanine aminotransferase increased  1/8 (12.50%)  9
Aspartate aminotransferase increased  1/8 (12.50%)  14
Blood glucose increased  1/8 (12.50%)  1
Blood creatinine increased  1/8 (12.50%)  1
Blood albumin decreased  1/8 (12.50%)  8
Blood potassium increased  1/8 (12.50%)  1
Blood calcium decreased  1/8 (12.50%)  2
Blood potassium decreased  1/8 (12.50%)  1
Neutrophil count decreased  2/8 (25.00%)  10
Platelet count decreased  1/8 (12.50%)  7
Serum albumin decreased  1/8 (12.50%)  1
White blood cell count decreased  3/8 (37.50%)  5
Musculoskeletal and connective tissue disorders   
Back pain  1/8 (12.50%)  1
Myalgia  1/8 (12.50%)  1
Nervous system disorders   
Headache  1/8 (12.50%)  3
Dysgeusia  1/8 (12.50%)  1
Renal and urinary disorders   
Chromaturia  1/8 (12.50%)  2
Skin and subcutaneous tissue disorders   
Dermal cyst  1/8 (12.50%)  1
1
Term from vocabulary, MedDRA (Unspecified)
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
Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01185028     History of Changes
Other Study ID Numbers: 100183
10-CC-0183
First Submitted: August 18, 2010
First Posted: August 19, 2010
Results First Submitted: March 21, 2013
Results First Posted: May 15, 2013
Last Update Posted: March 21, 2018