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

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ClinicalTrials.gov Identifier: NCT00991289
Recruitment Status : Completed
First Posted : October 8, 2009
Results First Posted : September 27, 2011
Last Update Posted : July 7, 2016
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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

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 Week 16   61 [2] 
COMPLETED   55 [3] 
NOT COMPLETED   12 
Adverse Event                1 
Physician Decision                2 
Withdrawal by Subject                3 
Lost to Follow-up                4 
Protocol Violation                2 
[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 continued to Week 76.
[3] Completed study.



  Baseline Characteristics

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
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 
Overall Participants Analyzed 
[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 
[1] Race/ethnicity, self-reported (NIH categories)
Region of Enrollment 
[Units: Participants]
 		 
United States   67 
HCV viral load level [1] 
[Units: Log10 IU/ml]
Median (Inter-Quartile Range) 		 6.4 
 (6.0 to 6.7) 
[1] Hepatitis C virus (HCV) viral load testing was done using Cobas AmpliPrep/Taqman HCV Test with lower limit of quantitation of 43 IU/ml.
CD4+ T cell count 
[Units: Cells/mm3]
Median (Inter-Quartile Range) 		 452 
 (323 to 738) 
Number of participants with indicated HIV viral load [1] 
[Units: Participant]
 		 
Undetectable HIV viral load   49 
Detectable HIV viral load   16 
Unknown   2 
[1] 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.
HIV Antiretroviral therapy (ART) status 
[Units: Participant]
 		 
On ART   61 
Not on ART   6 


  Outcome Measures

1.  Primary:   Percentage of Participants With Complete Early Virologic Response (cEVR)   [ Time Frame: Week 16 ]
  Show Outcome Measure 1

2.  Primary:   Percentage of Participants With Early Virologic Response (EVR)   [ Time Frame: Weeks 0, 16 ]
  Show Outcome Measure 2

3.  Secondary:   Percentage of Participants With Sustained Virologic Response (SVR)   [ Time Frame: 24 weeks after treatment discontinuation ]
  Show Outcome Measure 3

4.  Secondary:   Percentage of Participants With Rapid Virologic Response (RVR)   [ Time Frame: Week 8 ]
  Hide Outcome Measure 4

Measure Type Secondary
Measure Title Percentage of Participants With Rapid Virologic Response (RVR)
Measure Description Rapid virologic response (RVR) was defined as undetectable HCV viral load (<43 IU/ml) at Week 8 where 43 is the lower limit of quantification of the assay (Cobas AmpliPrep/Taqman HCV Test).
Time Frame Week 8  

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 8 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 
Participants Analyzed 
[Units: Participants]
 		 67 
Percentage of Participants With Rapid Virologic Response (RVR) 
[Units: Percentage of participants]
Number (90% Confidence Interval) 		 10.4 
 (5.0 to 18.7) 

No statistical analysis provided for Percentage of Participants With Rapid Virologic Response (RVR)



5.  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 5

6.  Secondary:   Change in Hemoglobin Level From Study Entry   [ Time Frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76. ]
  Show Outcome Measure 6

7.  Secondary:   Percent Change in Fasting Insulin Level From Study Entry   [ Time Frame: Weeks 0, 16, 28, 52, and 76 ]
  Show Outcome Measure 7

8.  Secondary:   Percent Change in Fasting Glucose Level From Study Entry   [ Time Frame: Weeks 0, 16, 28, 52, and 76 ]
  Show Outcome Measure 8

9.  Secondary:   Percent Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Study Entry   [ Time Frame: Weeks 0, 16, 28, 52, and 76 ]
  Show Outcome Measure 9

10.  Secondary:   Change in log10 HCV Viral Load After 4 Weeks of Nitazoxanide (NTZ) Monotherapy.   [ Time Frame: Weeks 0, 4 ]
  Show Outcome Measure 10

11.  Secondary:   Number of Participants With HCV Genotype 1   [ Time Frame: Week 0 ]
  Show Outcome Measure 11


  Serious Adverse Events


  Other Adverse Events


  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
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  More Information