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Nitazoxanide Plus Ribavirin and Peginterferon for Therapy of Treatment Naive HCV Genotype 1 and HIV Coinfected Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00991289
First received: October 7, 2009
Last updated: October 1, 2012
Last verified: October 2012
History of Changes
Results First Received: August 29, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: HIV Infection
Hepatitis C Infection
Interventions: Drug: Nitazoxanide (NTZ)
Drug: Pegylated interferon alfa-2a (PEG)
Drug: Ribavirin (RBV)

  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
Men and women at least 18 years of age with genotype 1 hepatitis C virus (HCV) and human immunodeficiency virus (HIV) coinfection and naive to previous HCV treatment were recruited for participation in this study.

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
NTZ/PEG/RBV Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.

Participant Flow:   Overall Study
    NTZ/PEG/RBV  
STARTED     67 [1]
COMPLETED     61 [2]
NOT COMPLETED     6  
Adverse Event                 1  
Physician Decision                 1  
Lost to Follow-up                 4  
[1] 68 participants enrolled, one was found to have been ineligible and was excluded.
[2] Completed 16 weeks of the study (the primary endpoint time point). The study is ongoing to Week 76.



  Baseline Characteristics
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Reporting Groups
  Description
NTZ/PEG/RBV Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.

Baseline Measures
    NTZ/PEG/RBV  
Number of Participants  
[units: participants]
 		  67  
Age  
[units: years]
Mean ± Standard Deviation 		  48.1  ± 8.5  
Age, Customized  
[units: participants]
 		 
<25 years     1  
25 to <30 years     1  
30 to <35 years     4  
35 to <40 years     3  
40 to <45 years     11  
45 to <50 years     13  
50 to <55 years     18  
55 to 60 years     13  
>=60 years     3  
Gender  
[units: participants]
 		 
Female     15  
Male     52  
Race/Ethnicity, Customized [1]
[units: Participants]
 		 
White, Non-Hispanic     21  
Black, Non-Hispanic     32  
Hispanic, Regardless of Race     12  
Other/Unknown     2  
Region of Enrollment  
[units: participants]
 		 
United States     67  
HCV viral load level [2]
[units: log10 IU/ml]
Median ( Inter-Quartile Range ) 		  6.4  
  ( 6.0 to 6.7 )  
CD4+ T cell count  
[units: cells/mm3]
Median ( Inter-Quartile Range ) 		  452  
  ( 323 to 738 )  
Number of participants with indicated HIV viral load [3]
[units: participant]
 		 
Undetectable HIV viral load     49  
Detectable HIV viral load     16  
Unknown     2  
HIV Antiretroviral therapy (ART) status  
[units: participant]
 		 
On ART     61  
Not on ART     6  
[1] Race/ethnicity, self-reported (NIH categories)
[2] Hepatitis C virus (HCV) viral load testing was done using Cobas AmpliPrep/Taqman HCV Test with lower limit of quantitation of 43 IU/ml.
[3] A blood sample was drawn to determine the HIV viral load by local laboratories. HIV viral load was categorized as <lower limit of quantification (undetectable) of the assay or >=lower limit of quantification of the assay (detectable). The assays used were bDNA assay (Versant HIV-1 RNA 3.0), Roche COBAS AmpliPrp/Taqman HIV-1 assay and Abbott RealTime HIV-1 assay.



  Outcome Measures
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1.  Primary:   Percentage of Participants With Complete Early Virologic Response (cEVR)   [ Time Frame: Week 16 ]
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Measure Type Primary
Measure Title Percentage of Participants With Complete Early Virologic Response (cEVR)
Measure Description Complete early virologic response (cEVR) was defined as undetectable HCV viral load (<43 IU/ml) at week 16, where 43 is the lower limit of quantification of the assay (Cobas AmpliPrep/Taqman HCV Test).
Time Frame Week 16  
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.
All participants who enrolled, except one participant who was found to have been ineligible after entry. The analysis was intention to treat wherein participants who dropped out early without Week 16 HCV viral load result were considered non-responders.

Reporting Groups
  Description
NTZ/PEG/RBV Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.

Measured Values
    NTZ/PEG/RBV  
Number of Participants Analyzed  
[units: participants]
 		  67  
Percentage of Participants With Complete Early Virologic Response (cEVR)  
[units: percentage of participants]
Number ( 90% Confidence Interval ) 		  38.8  
  ( 28.8 to 49.6 )  

No statistical analysis provided for Percentage of Participants With Complete Early Virologic Response (cEVR)



2.  Primary:   Percentage of Participants With Early Virologic Response (EVR)   [ Time Frame: Week 16 ]
  Show Outcome Measure 2

3.  Secondary:   Percentage of Participants With Rapid Virologic Response (RVR)   [ Time Frame: Week 8 ]
  Show Outcome Measure 3

4.  Secondary:   Number of Participants With Adverse Events of Grade 2 or Higher   [ Time Frame: From study entry to up to week 76 ]
  Show Outcome Measure 4

5.  Secondary:   Change in Hemoglobin Level From Study Entry   [ Time Frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76. ]
  Show Outcome Measure 5

6.  Secondary:   Change in log10 HCV Viral Load After 4 Weeks of Nitazoxanide (NTZ) Monotherapy.   [ Time Frame: Week 4 ]
  Show Outcome Measure 6

7.  Secondary:   Number of Subjects With Interferon (IFN)-Responsive Proteins Present in Stored Peripheral Blood Mononuclear Cells (PBMCs) Based on In Vitro Assessment.   [ Time Frame: Every 4 weeks from entry to Week 52, and at Weeks 64 and 76 ]
  Show Outcome Measure 7

8.  Secondary:   Percentage of Participants With Sustained Virologic Response (SVR)   [ Time Frame: 24 weeks after treatment discontinuation ]
Results not yet posted.   Anticipated Posting Date:   12/2012   Safety Issue:   No

9.  Secondary:   Fasting Insulin Level   [ Time Frame: Weeks 0, 16, 28, 52, and 76 ]
Results not yet posted.   Anticipated Posting Date:   12/2012   Safety Issue:   No

10.  Secondary:   Fasting Glucose Level   [ Time Frame: Weeks 0, 16, 28, 52, and 76 ]
Results not yet posted.   Anticipated Posting Date:   12/2012   Safety Issue:   No

11.  Secondary:   Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)   [ Time Frame: Weeks 0, 16, 28, 52, and 76 ]
Results not yet posted.   Anticipated Posting Date:   12/2012   Safety Issue:   No

12.  Secondary:   Number of Participants With HCV Genotype 1   [ Time Frame: Week 0 ]
Results not yet posted.   Anticipated Posting Date:   12/2012   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Clinicaltrials.gov Coordinator
Organization: Center for Biostatistics in AIDS Research, Harvard School of Public Health
phone: (617) 432-2829
e-mail: CBAR.ClinicalTrials.Gov@sdac.harvard.edu


Publications:


Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00991289     History of Changes
Other Study ID Numbers: A5269, 10764, ACTG A5269
Study First Received: October 7, 2009
Results First Received: August 29, 2011
Last Updated: October 1, 2012
Health Authority: United States: Food and Drug Administration
United States: Federal Government