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: June 18, 2013
Last verified: June 2013
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
  Hide 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
  Hide 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  
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
  Hide All Outcome Measures

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

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: Weeks 0, 16 ]

Measure Type Primary
Measure Title Percentage of Participants With Early Virologic Response (EVR)
Measure Description Early virologic response (EVR) was defined as undetectable HCV viral load (<43 IU/ml) at Week 16 or at least a 2-log10 decrease in HCV viral load from study entry at Week 16, where 43 is the lower limit of quantification of the assay (Cobas AmpliPrep/Taqman HCV Test).
Time Frame Weeks 0, 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 Early Virologic Response (EVR)  
[units: percentage of participants]
Number ( 90% Confidence Interval )
  65.7  
  ( 55.0 to 75.3 )  

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



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

Measure Type Secondary
Measure Title Percentage of Participants With Sustained Virologic Response (SVR)
Measure Description Sustained virologic response (SVR) was defined as undetectable HCV viral load (<43 IU/ml) at 24 weeks after treatment discontinuation, where 43 is the lower limit of quantification of the assay (Cobas AmpliPrep/Taqman HCV Test). Participants who failed to achieve EVR or had detectable HCV RNA at Week 28 and per protocol discontinued study, and participants without HCV RNA from 24 weeks after treatment discontinuation, were considered non-responders.
Time Frame 24 weeks after treatment discontinuation  
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 who was found to have been ineligible after entry. The analysis was intention to treat wherein participants who dropped out early without HCV RNA from 24 weeks after treatment discontinuation, non-EVRs and those with detectable HCV RNA at Week 28, 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 Sustained Virologic Response (SVR)  
[units: percentage of participants]
Number ( 90% Confidence Interval )
  32.8  
  ( 23.4 to 43.5 )  

No statistical analysis provided for Percentage of Participants With Sustained Virologic Response (SVR)



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

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  
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 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  
Number of 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 ]

Measure Type Secondary
Measure Title Number of Participants With Adverse Events of Grade 2 or Higher
Measure Description Number of participants who experienced an adverse event of Grade 2 or higher at any time after study entry. Grading of adverse events (signs and symptoms and laboratory toxicities) was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004.
Time Frame From study entry to up to week 76  
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.
All participants who enrolled, except one participant who was found to have been ineligible after entry.

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  
Number of Participants With Adverse Events of Grade 2 or Higher  
[units: participants]
  65  

No statistical analysis provided for Number of Participants With Adverse Events of Grade 2 or Higher



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. ]

Measure Type Secondary
Measure Title Change in Hemoglobin Level From Study Entry
Measure Description Change in hemoglobin (HGB) was calculated as HGB at later time point (Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76) minus HGB at study entry.
Time Frame Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76.  
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.
All participants who enrolled, except one participant who was found to have been ineligible after entry, and had HGB measurement available at entry and at the respective post-entry time point: 65, 65, 63, 60, 55, 51, 45, 38, 39, 34, 31, 32, 31 and 29 participants at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 76, respectively.

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  
Change in Hemoglobin Level From Study Entry  
[units: g/dL]
Median ( Inter-Quartile Range )
 
Change in HGB at Week 4 (n=65)     -0.1  
  ( -0.6 to 0.4 )  
Change in HGB at Week 8 (n=65)     -2.1  
  ( -3.0 to -1.1 )  
Change in HGB at Week 12 (n=63)     -2.5  
  ( -3.5 to -1.8 )  
Change in HGB at Week 16 (n=60)     -2.5  
  ( -3.5 to -1.4 )  
Change in HGB at Week 20 (n=55)     -2.5  
  ( -3.8 to -1.3 )  
Change in HGB at Week 24 (n=51)     -2.4  
  ( -3.2 to -1.3 )  
Change in HGB at Week 28 (n=45)     -2.5  
  ( -3.4 to -1.6 )  
Change in HGB at Week 32 (n=38)     -2.7  
  ( -3.4 to -1.7 )  
Change in HGB at Week 36 (n=39)     -2.5  
  ( -3.9 to -1.7 )  
Change in HGB at Week 40 (n=34)     -2.6  
  ( -3.4 to -2.1 )  
Change in HGB at Week 44 (n=31)     -2.6  
  ( -3.9 to -1.6 )  
Change in HGB at Week 48 (n=32)     -2.7  
  ( -3.4 to -1.9 )  
Change in HGB at Week 52 (n=31)     -2.9  
  ( -3.8 to -1.6 )  
Change in HGB at Week 76 (n=29)     -0.9  
  ( -1.3 to -0.5 )  

No statistical analysis provided for Change in Hemoglobin Level From Study Entry



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

Measure Type Secondary
Measure Title Percent Change in Fasting Insulin Level From Study Entry
Measure Description Percent Change in fasting insulin (FINS) was calculated as FINS at later time point (16, 28, 52, 76) minus FINS at study entry, divided by FINS at study entry x 100%. Study protocol required fasting for at least 8 hours (nothing by mouth except medications and water) prior to specimen collection for fasting insulin testing.
Time Frame Weeks 0, 16, 28, 52, and 76  
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, and had FINS measurement available at entry and the respective post-entry time point: 58 at Week 16, 40 at Week 28, 28 at Week 52 and 23 at Week 76.

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  
Percent Change in Fasting Insulin Level From Study Entry  
[units: percentage of FINS at study entry]
Median ( Inter-Quartile Range )
 
Percent change in FINS at Week 16 (n=58)     0  
  ( -30.8 to 64.7 )  
Percent change in FINS at Week 28 (n=40)     8.8  
  ( -33.2 to 67.9 )  
Percent change in FINS at Week 52 (n=28)     28.2  
  ( -15.0 to 87.5 )  
Percent change in FINS at Week 76 (n=23)     8.3  
  ( -48.0 to 56.3 )  

No statistical analysis provided for Percent Change in Fasting Insulin Level From Study Entry



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

Measure Type Secondary
Measure Title Percent Change in Fasting Glucose Level From Study Entry
Measure Description Percent Change in fasting glucose (FGLUC) was calculated as FGLUC at later time point (16, 28, 52, 76) minus FGLUC at study entry, divided by FGLUC at study entry x 100%. Study protocol required fasting for at least 8 hours (nothing by mouth except medications and water) prior to specimen collection for fasting glucose testing.
Time Frame Weeks 0, 16, 28, 52, and 76  
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, and had FGLUC measurement available at entry and the respective post-entry time point: 58 at Week 16, 41 at Week 28, 29 at Week 52 and 24 at Week 76.

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  
Percent Change in Fasting Glucose Level From Study Entry  
[units: percentage of FGLUC at study entry]
Median ( Inter-Quartile Range )
 
Percent change in FGLUC at Week 16 (n=58)     -3.2  
  ( -12.6 to 7.0 )  
Percent change in FGLUC at Week 28 (n=41)     -5.3  
  ( -9.9 to 4.9 )  
Percent change in FGLUC at Week 52 (n=29)     1.1  
  ( -11.8 to 8.0 )  
Percent change in FGLUC at Week 76 (n=24)     0  
  ( -7.4 to 8.4 )  

No statistical analysis provided for Percent Change in Fasting Glucose Level From Study Entry



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 ]

Measure Type Secondary
Measure Title Percent Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Study Entry
Measure Description HOMA-IR was calculated as [fasting glucose (mg/dL) x fasting insulin (uIU/mL)]/405. Percent Change in HOMA-IR was calculated as HOMA-IR at later time point (16, 28, 52, 76) minus HOMA-IR at study entry, divided by HOMA-IR at study entry x 100%. Study protocol required fasting for at least 8 hours (nothing by mouth except medications and water) prior to specimen collection for fasting insulin and fasting glucose testing.
Time Frame Weeks 0, 16, 28, 52, and 76  
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, and had fasting insulin and fasting glucose measurements available at entry and the respective post-entry time point: 56 at Week 16, 39 at Week 28, 27 at Week 52 and 22 at Week 76.

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  
Percent Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Study Entry  
[units: percentage of HOMA-IR at study entry]
Median ( Inter-Quartile Range )
 
Percent change in HOMA-IR at Week 16 (n=56)     -13.0  
  ( -31.6 to 64.2 )  
Percent change in HOMA-IR at Week 28 (n=39)     -6.3  
  ( -42.7 to 81.1 )  
Percent change in HOMA-IR at Week 52 (n=27)     23.2  
  ( -24.2 to 87.1 )  
Percent change in HOMA-IR at Week 76 (n=22)     9.5  
  ( -48.0 to 59.5 )  

No statistical analysis provided for Percent Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Study Entry



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

Measure Type Secondary
Measure Title Change in log10 HCV Viral Load After 4 Weeks of Nitazoxanide (NTZ) Monotherapy.
Measure Description Change in log10 HCV viral load was calculated as log10-transformed HCV viral load at Week 4 minus log10-transformed HCV viral load at study entry. HCV viral load testing was done using Cobas AmpliPrep/Taqman HCV Test.
Time Frame Weeks 0, 4  
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, and had HCV viral load measurements available at entry and at Week 4 were analyzed.

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]
  64  
Change in log10 HCV Viral Load After 4 Weeks of Nitazoxanide (NTZ) Monotherapy.  
[units: log10 IU/mL]
Median ( Inter-Quartile Range )
  -0.12  
  ( -0.30 to 0.13 )  

No statistical analysis provided for Change in log10 HCV Viral Load After 4 Weeks of Nitazoxanide (NTZ) Monotherapy.



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

Measure Type Secondary
Measure Title Number of Participants With HCV Genotype 1
Measure Description Confirmatory HCV genotyping was performed on stored plasma from entry using VERSANT HCV Genotype assay v2.0 (LiPA, RUO, Siemens Healthcare Diagnostics Inc., Tarrytown, NY).
Time Frame Week 0  
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.

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  
Number of Participants With HCV Genotype 1  
[units: participants]
  67  

No statistical analysis provided for Number of Participants With HCV Genotype 1




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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.


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: June 18, 2013
Health Authority: United States: Food and Drug Administration
United States: Federal Government