Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Pegylated Interferon Alfa-2a Maintenance Therapy and Liver Disease Progression in People Infected With Both HIV and Hepatitis C Virus (HCV)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00078403
First received: February 24, 2004
Last updated: August 13, 2014
Last verified: August 2014
Results First Received: November 5, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: HIV Infections
Hepatitis C
Liver Disease
Interventions: Drug: Peginterferon alfa-2a
Drug: Ribavirin

  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
People with hepatitis C virus (HCV)/HIV coinfection 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
330 subjects were to receive 12 weeks of PEG+RBV to determine EVR status. Of the 330, 33 discontinued prior to week 12; 113 were non-EVRs, 80 of whom were randomized between Arms A and B; and 184 achieved EVR, 170 of whom were eligible to continue. 169 of the 170 were assigned to Arm C and one was inadvertently randomized between Arms A and B.

Reporting Groups
  Description
Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) At week 12 (end of the initial run-in period – Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to receive the pegylated interferon (PEG-IFN) 180 mcg weekly Arm.
OL (PEG-IFN, RBV) Then OL Randomized (Observation) At week 12 (end of the initial run-in period – Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to be followed on the Observation (no treatment) Arm.
OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) At week 12 (end of initial run-in period, Step 1) participants were found to be HCV RNA negative (HCV RNA < 60 IU/mL) or had more than a 2 log decrease in HCV RNA from Baseline. Participants were assigned to remain in the Open Label (OL) part of the study continuing the run-in treatment (PEG-IFN 180 mcg weekly & ribavirin [RBV] 1-1.2 g/day based on weight). At the beginning of week 36, participants were retested and, if found to be HCV RNA positive (HCV RNA > 60 IU/mL), participants could be randomized to OL PEG-IFN or Observation.

Participant Flow:   Overall Study
    Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)     OL (PEG-IFN, RBV) Then OL Randomized (Observation)     OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)  
STARTED     44 [1]   42 [2]   169  
COMPLETED     26     26     141  
NOT COMPLETED     18     16     28  
[1] Eligible at pre-assignment (40), direct (2), Arm C week 36 non-response (1), EVR inadvertently (1).
[2] Eligible at pre-assignment (40), direct (1), Arm C week 36 non-response (1).



  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.
No text entered.

Reporting Groups
  Description
Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) At week 12 (end of the initial run-in period – Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to receive the pegylated interferon (PEG-IFN) 180 mcg weekly Arm.
OL (PEG-IFN, RBV) Then OL Randomized (Observation) At week 12 (end of the initial run-in period – Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to be followed on the Observation (no treatment) Arm.
OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) At week 12 (end of initial run-in period, Step 1) participants were found to be HCV RNA negative (HCV RNA < 60 IU/mL) or had more than a 2 log decrease in HCV RNA from Baseline. Participants were assigned to remain in the Open Label (OL) part of the study continuing the run-in treatment (PEG-IFN 180 mcg weekly & ribavirin [RBV] 1-1.2 g/day based on weight). At the beginning of week 36, participants were retested and, if found to be HCV RNA positive (HCV RNA > 60 IU/mL), participants could be randomized to OL PEG-IFN or Observation.
Total Total of all reporting groups

Baseline Measures
    Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)     OL (PEG-IFN, RBV) Then OL Randomized (Observation)     OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)     Total  
Number of Participants  
[units: participants]
  44     42     169     255  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     44     42     169     255  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  48.8  ± 6.7     48.1  ± 5.8     47.2  ± 7.1     47.6  ± 6.8  
Gender  
[units: participants]
       
Female     12     12     19     43  
Male     32     30     150     212  
Region of Enrollment  
[units: participants]
       
United States     41     40     168     249  
Puerto Rico     3     2     1     6  



  Outcome Measures
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1.  Primary:   Time-scaled Change in Metavir Liver Fibrosis Score (SCMFS)   [ Time Frame: Baseline and at week 72 or premature discontinuation ]

Measure Type Primary
Measure Title Time-scaled Change in Metavir Liver Fibrosis Score (SCMFS)
Measure Description SCMFS is the difference between the Metavir fibrosis scores of the study exit and study entry liver biopsies where the difference is scaled to one year. The SCMFS assesses the annualized change in the severity of liver fibrosis on a continuous scale from -4.0 Metavir units per year (reduced fibrosis over time, a positive study outcome) to +4.0 Metavir units per year (increased fibrosis over time).
Time Frame Baseline and at week 72 or premature 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.
62 Arm A and B participants who had follow-up liver biopsy performed or those who had Week 72 potential as of May 2, 2007 but no follow-up liver biopsy. In the unadjusted ITT analysis, the participants without SCMFS available were assigned the highest SCMFS (+2).

Reporting Groups
  Description
A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) At week 12 (end of the initial run-in period – Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to receive the pegylated interferon (PEG-IFN) 180 mcg weekly Arm.
B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) At week 12 (end of the initial run-in period – Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to be followed on the Observation (no treatment) Arm.
C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) At week 12 (end of initial run-in period, Step 1) participants were found to be HCV RNA negative (HCV RNA < 60 IU/mL) or had more than a 2 log decrease in HCV RNA from Baseline. Participants were assigned to remain in the Open Label (OL) part of the study continuing the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight). At the beginning of week 36, participants were retested and, if found to be HCV RNA positive (HCV RNA > 60 IU/mL), participants could be randomized to OL PEG-IFN or Observation.

Measured Values
    A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)     B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)     C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)  
Number of Participants Analyzed  
[units: participants]
  33     29     0  
Time-scaled Change in Metavir Liver Fibrosis Score (SCMFS)  
[units: Metavir units per one year (52 weeks)]
Median ( Inter-Quartile Range )
  0  
  ( 0 to 1.37 )  
  0  
  ( 0 to 2 )  
   
   


Statistical Analysis 1 for Time-scaled Change in Metavir Liver Fibrosis Score (SCMFS)
Groups [1] A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) vs. B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)
Method [2] Exact Wilcoxon rank sum test
P Value [3] 0.58
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Accrual and follow-up on Arms A and B were halted for futility at the first independent interim review of the primary endpoint conducted on May 2, 2007.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  P-value is pre-specified 1-sided test that PEG slows liver fibrosis progression. Accrual and follow-up on Arms A and B were halted at interim review for lack of fibrosis progression in Arm B (control arm). P-value is unadjusted for interim analysis.



2.  Secondary:   Number of Participants With Detectable HCV RNA Viral Load (>= 60 IU/mL)   [ Time Frame: Arms A and B: Weeks 0, 12, 24, 48 and 72; Arm C: Weeks 0, 12, 24, 36, 60, 72, 84 ]

Measure Type Secondary
Measure Title Number of Participants With Detectable HCV RNA Viral Load (>= 60 IU/mL)
Measure Description Qualitative plasma HCV viral load was categorized as less than 60 IU/mL vs greater than 60 IU/mL whereas 60 IU/mL is the lower limit of qualitative assay
Time Frame Arms A and B: Weeks 0, 12, 24, 48 and 72; Arm C: Weeks 0, 12, 24, 36, 60, 72, 84  
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 Arm A, B and C participants

Reporting Groups
  Description
A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) At week 12 (end of the initial run-in period – Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to receive the pegylated interferon (PEG-IFN) 180 mcg weekly Arm.
B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) At week 12 (end of the initial run-in period – Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to be followed on the Observation (no treatment) Arm.
C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) At week 12 (end of initial run-in period, Step 1) participants were found to be HCV RNA negative (HCV RNA < 60 IU/mL) or had more than a 2 log decrease in HCV RNA from Baseline. Participants were assigned to remain in the Open Label (OL) part of the study continuing the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight). At the beginning of week 36, participants were retested and, if found to be HCV RNA positive (HCV RNA > 60 IU/mL), participants could be randomized to OL PEG-IFN or Observation.

Measured Values
    A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)     B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)     C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)  
Number of Participants Analyzed  
[units: participants]
  44     42     169  
Number of Participants With Detectable HCV RNA Viral Load (>= 60 IU/mL)  
[units: Participant]
     
Week 0--Number of participants with HCV RNA data     44     42     164  
Week 0--Number of participants with detectable HCV     42     42     53  
Week 12--Number of participants with HCV RNA data     42     34     158  
Week 12-Number of participants with detectable HCV     40     34     31  
Week 24--Number of participants with HCV RNA data     36     35     163  
Week 24-Number of participants with detectable HCV     35     35     39  
Week 36--Number of participants with HCV RNA data     0     0     158  
Week 36-Number of participants with detectable HCV     NA [1]   NA [1]   41  
Week 48--Number of participants with HCV RNA data     31     28     0  
Week 48-Number of participants with detectable HCV     31     28     NA [1]
Week 60--Number of participants with HCV RNA data     0     0     137  
Week 60-Number of participants with detectable HCV     NA [1]   NA [1]   34  
Week 72--Number of participants with HCV RNA data     27     22     135  
Week 72-Number of participants with detectable HCV     27     22     51  
Week 84--Number of participants with HCV RNA data     0     0     137  
Week 84-Number of participants with detectable HCV     NA [1]   NA [1]   50  
[1] Test not specified in protocol at this time point.

No statistical analysis provided for Number of Participants With Detectable HCV RNA Viral Load (>= 60 IU/mL)



3.  Secondary:   Time-scaled Change in Ishak Liver Inflammation Score (SCIIS)   [ Time Frame: Baseline and at week 72 or premature discontinuation ]

Measure Type Secondary
Measure Title Time-scaled Change in Ishak Liver Inflammation Score (SCIIS)
Measure Description Liver biopsies were performed within 42 days prior to randomization between Arms A and B while the participant remained on PEG-IFN plus RBV (=entry biopsy) and again at week 72 or premature study discontinuation (=exit biopsy). SCIIS was defined as the difference between the Ishak inflammation score of the exit biopsy and the Ishak inflammation score of the entry biopsy, where the difference is scaled to one year.
Time Frame Baseline and at week 72 or premature 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 with SCIIS available (Complete Cases)

Reporting Groups
  Description
A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) At week 12 (end of the initial run-in period – Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to receive the pegylated interferon (PEG-IFN) 180 mcg weekly Arm.
B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) At week 12 (end of the initial run-in period – Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to be followed on the Observation (no treatment) Arm.
C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) At week 12 (end of initial run-in period, Step 1) participants were found to be HCV RNA negative (HCV RNA < 60 IU/mL) or had more than a 2 log decrease in HCV RNA from Baseline. Participants were assigned to remain in the Open Label (OL) part of the study continuing the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight). At the beginning of week 36, participants were retested and, if found to be HCV RNA positive (HCV RNA > 60 IU/mL), participants could be randomized to OL PEG-IFN or Observation.

Measured Values
    A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)     B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)     C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)  
Number of Participants Analyzed  
[units: participants]
  44     42     0  
Time-scaled Change in Ishak Liver Inflammation Score (SCIIS)  
[units: Ishak units per one year (52 weeks)]
Median ( Inter-Quartile Range )
  0  
  ( -0.75 to 1.79 )  
  1.31  
  ( 0 to 2.10 )  
   
   

No statistical analysis provided for Time-scaled Change in Ishak Liver Inflammation Score (SCIIS)



4.  Secondary:   Number of Participants With Anemia   [ Time Frame: Up to 96 weeks ]

Measure Type Secondary
Measure Title Number of Participants With Anemia
Measure Description Number of participants with anemia by grade (defined by hemoglobin level in grams per deciliter; g/dL). DAIDS Toxicity Grading Table (1992) was used for grading where Grade 1 = hemoglobin of 8 to 9.4 g/dl; Grade 2 = 7 to 7.9 g/dl; Grade 3 = 6.5 to 6.9 g/dl; Grade 4 = below 6.5 g/dl.
Time Frame Up to 96 weeks  
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 Arm A, B and C participants

Reporting Groups
  Description
A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) At week 12 (end of the initial run-in period – Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to receive the pegylated interferon (PEG-IFN) 180 mcg weekly Arm.
B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) At week 12 (end of the initial run-in period – Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to be followed on the Observation (no treatment) Arm.
C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) At week 12 (end of initial run-in period, Step 1) participants were found to be HCV RNA negative (HCV RNA < 60 IU/mL) or had more than a 2 log decrease in HCV RNA from Baseline. Participants were assigned to remain in the Open Label (OL) part of the study continuing the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight). At the beginning of week 36, participants were retested and, if found to be HCV RNA positive (HCV RNA > 60 IU/mL), participants could be randomized to OL PEG-IFN or Observation.

Measured Values
    A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)     B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)     C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)  
Number of Participants Analyzed  
[units: participants]
  44     42     169  
Number of Participants With Anemia  
[units: Participant]
     
Anemia >= Grade 2     1     0     6  
Grade 2     0     0     3  
Grade 3     0     0     1  
Grade 4     1     0     2  

No statistical analysis provided for Number of Participants With Anemia



5.  Secondary:   Number of Participants With Neutropenia   [ Time Frame: Up to 96 weeks ]

Measure Type Secondary
Measure Title Number of Participants With Neutropenia
Measure Description Number of participants with neutropenia by grade (defined by absolute neutrophil count [ANC] per cubic millimeter; mm3). DAIDS Toxicity Grading Table (1992) was used for grading where Grade 1 = ANC of 1000 to 1500 /mm3; Grade 2 = 750 to 999 /mm3; Grade 3 = 500 to 749 /mm3; Grade 4 = below 500 /mm3.
Time Frame Up to 96 weeks  
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 Arm A, B and C participants

Reporting Groups
  Description
A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) At week 12 (end of the initial run-in period – Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to receive the pegylated interferon (PEG-IFN) 180 mcg weekly Arm.
B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) At week 12 (end of the initial run-in period – Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to be followed on the Observation (no treatment) Arm.
C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) At week 12 (end of initial run-in period, Step 1) participants were found to be HCV RNA negative (HCV RNA < 60 IU/mL) or had more than a 2 log decrease in HCV RNA from Baseline. Participants were assigned to remain in the Open Label (OL) part of the study continuing the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight). At the beginning of week 36, participants were retested and, if found to be HCV RNA positive (HCV RNA > 60 IU/mL), participants could be randomized to OL PEG-IFN or Observation.

Measured Values
    A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)     B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)     C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)  
Number of Participants Analyzed  
[units: participants]
  44     42     169  
Number of Participants With Neutropenia  
[units: Participant]
     
Neutropenia >= Grade 2     20     10     96  
Grade 2     7     4     38  
Grade 3     10     5     37  
Grade 4     3     1     21  

No statistical analysis provided for Number of Participants With Neutropenia



6.  Secondary:   Number of Participants With Thrombocytopenia   [ Time Frame: Up to 96 weeks ]

Measure Type Secondary
Measure Title Number of Participants With Thrombocytopenia
Measure Description Number of participants with thrombocytopenia by grade (defined by platelet count per cubic millimeter; mm3). DAIDS Toxicity Grading Table (1992) was used for grading where Grade 1 = platelets of 75,000 to 99,000 /mm3; Grade 2 = 50,000 to 74,999 /mm3; Grade 3 = 20,000 to 49,999 /mm3; Grade 4 = below 20,000 /mm3.
Time Frame Up to 96 weeks  
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 Arm A, B and C participants

Reporting Groups
  Description
A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) At week 12 (end of the initial run-in period – Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to receive the pegylated interferon (PEG-IFN) 180 mcg weekly Arm.
B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) At week 12 (end of the initial run-in period – Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to be followed on the Observation (no treatment) Arm.
C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) At week 12 (end of initial run-in period, Step 1) participants were found to be HCV RNA negative (HCV RNA < 60 IU/mL) or had more than a 2 log decrease in HCV RNA from Baseline. Participants were assigned to remain in the Open Label (OL) part of the study continuing the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight). At the beginning of week 36, participants were retested and, if found to be HCV RNA positive (HCV RNA > 60 IU/mL), participants could be randomized to OL PEG-IFN or Observation.

Measured Values
    A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)     B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)     C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)  
Number of Participants Analyzed  
[units: participants]
  44     42     169  
Number of Participants With Thrombocytopenia  
[units: Participant]
     
Thrombocytopenia >= Grade 2     14     4     31  
Grade 2     10     3     25  
Grade 3     4     1     5  
Grade 4     0     0     1  

No statistical analysis provided for Number of Participants With Thrombocytopenia



7.  Secondary:   Number of Participants With Depression and/or Other Psychological Events   [ Time Frame: Up to 96 weeks ]

Measure Type Secondary
Measure Title Number of Participants With Depression and/or Other Psychological Events
Measure Description Depression and other psychological events. DAIDS Toxicity Grading Table (1992) was used for grading. The protocol required reporting of depression and other psychological events of Grade 3 or higher or if led to a change in treatment, regardless of grade.
Time Frame Up to 96 weeks  
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 Arm A, B and C participants

Reporting Groups
  Description
A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) At week 12 (end of the initial run-in period – Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to receive the pegylated interferon (PEG-IFN) 180 mcg weekly Arm.
B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) At week 12 (end of the initial run-in period – Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to be followed on the Observation (no treatment) Arm.
C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) At week 12 (end of initial run-in period, Step 1) participants were found to be HCV RNA negative (HCV RNA < 60 IU/mL) or had more than a 2 log decrease in HCV RNA from Baseline. Participants were assigned to remain in the Open Label (OL) part of the study continuing the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight). At the beginning of week 36, participants were retested and, if found to be HCV RNA positive (HCV RNA > 60 IU/mL), participants could be randomized to OL PEG-IFN or Observation.

Measured Values
    A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)     B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)     C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)  
Number of Participants Analyzed  
[units: participants]
  44     42     169  
Number of Participants With Depression and/or Other Psychological Events  
[units: Participant]
     
Any psychological     3     1     19  
Grade 3     2     1     18  
Grade 4     1     0     1  

No statistical analysis provided for Number of Participants With Depression and/or Other Psychological Events



8.  Secondary:   Other High-grade Signs and Symptoms and Laboratory Values   [ Time Frame: Up to 96 Weeks ]

Measure Type Secondary
Measure Title Other High-grade Signs and Symptoms and Laboratory Values
Measure Description Number of participants with “Other high-grade signs and symptoms and laboratory values. DAIDS Toxicity Grading Table (1992) was used for grading where Grade 1 = transient/mild discomfort, no limitation in activity, no medical intervention; Grade 2 = mild/moderate limitation in activity, some assistance, no/minimal medical intervention; Grade 3 = marked limitation in activity, some assistance, medical intervention required); Grade 4 = extreme limitation in activity, significant medical intervention, assistance, hospitalization.
Time Frame Up to 96 Weeks  
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 Arm A, B and C participants

Reporting Groups
  Description
A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) At week 12 (end of the initial run-in period – Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to receive the pegylated interferon (PEG-IFN) 180 mcg weekly Arm.
B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) At week 12 (end of the initial run-in period – Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to be followed on the Observation (no treatment) Arm.
C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) At week 12 (end of initial run-in period, Step 1) participants were found to be HCV RNA negative (HCV RNA < 60 IU/mL) or had more than a 2 log decrease in HCV RNA from Baseline. Participants were assigned to remain in the Open Label (OL) part of the study continuing the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight). At the beginning of week 36, participants were retested and, if found to be HCV RNA positive (HCV RNA > 60 IU/mL), participants could be randomized to OL PEG-IFN or Observation.

Measured Values
    A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)     B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)     C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)  
Number of Participants Analyzed  
[units: participants]
  44     42     169  
Other High-grade Signs and Symptoms and Laboratory Values  
[units: Participant]
     
Any Other     22     20     84  
Grade 3     15     15     73  
Grade 4     7     5     11  

No statistical analysis provided for Other High-grade Signs and Symptoms and Laboratory Values



9.  Secondary:   Number of Participants With Dose Modifications, Temporary Stops, and Premature Treatment Discontinuations   [ Time Frame: Up to 96 Weeks ]

Measure Type Secondary
Measure Title Number of Participants With Dose Modifications, Temporary Stops, and Premature Treatment Discontinuations
Measure Description 3-level categorical of the worst of 1) premature treatment discontinuation, 2) temporary stop or 3) dose reduction. For Arm C, the worst for either PEG-IFN or RBV is summarized.
Time Frame Up to 96 Weeks  
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 Arm A and C participants. Arm B participants did not receive treatment.

Reporting Groups
  Description
A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) At week 12 (end of the initial run-in period – Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to receive the pegylated interferon (PEG-IFN) 180 mcg weekly Arm.
B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) At week 12 (end of the initial run-in period – Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to be followed on the Observation (no treatment) Arm.
C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) At week 12 (end of initial run-in period, Step 1) participants were found to be HCV RNA negative (HCV RNA < 60 IU/mL) or had more than a 2 log decrease in HCV RNA from Baseline. Participants were assigned to remain in the Open Label (OL) part of the study continuing the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight). At the beginning of week 36, participants were retested and, if found to be HCV RNA positive (HCV RNA > 60 IU/mL), participants could be randomized to OL PEG-IFN or Observation.

Measured Values
    A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)     B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)     C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)  
Number of Participants Analyzed  
[units: participants]
  44     0     169  
Number of Participants With Dose Modifications, Temporary Stops, and Premature Treatment Discontinuations  
[units: Participant]
     
Premature treatment discontinuation     16         57  
Temporarily off treatment     7         29  
Reduced dose     2         33  

No statistical analysis provided for Number of Participants With Dose Modifications, Temporary Stops, and Premature Treatment Discontinuations



10.  Secondary:   Number of Participants Adherent to Study Medications   [ Time Frame: Arm A: at weeks 12, 24, 48 and 72. Arm C: at entry and weeks 12, 24, 48, 60. ]

Measure Type Secondary
Measure Title Number of Participants Adherent to Study Medications
Measure Description A categorical variable with levels adherent and non-adherent based on participants' self report. For Arm A, adherence was defined as not missing PEG within 2 weeks of visit. For Arm C, adherence was defined as not missing any PEG within 2 weeks of visit and not missing RBV within 4 days of visit.
Time Frame Arm A: at weeks 12, 24, 48 and 72. Arm C: at entry and weeks 12, 24, 48, 60.  
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 Arm A and Arm C participants. Arm B participants did not receive treatment.

Reporting Groups
  Description
A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) At week 12 (end of the initial run-in period – Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to receive the pegylated interferon (PEG-IFN) 180 mcg weekly Arm.
B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) At week 12 (end of the initial run-in period – Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to be followed on the Observation (no treatment) Arm.
C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) At week 12 (end of initial run-in period, Step 1) participants were found to be HCV RNA negative (HCV RNA < 60 IU/mL) or had more than a 2 log decrease in HCV RNA from Baseline. Participants were assigned to remain in the Open Label (OL) part of the study continuing the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight). At the beginning of week 36, participants were retested and, if found to be HCV RNA positive (HCV RNA > 60 IU/mL), participants could be randomized to OL PEG-IFN or Observation.

Measured Values
    A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)     B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)     C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)  
Number of Participants Analyzed  
[units: participants]
  44     0     159  
Number of Participants Adherent to Study Medications  
[units: Participant]
     
Week 0: Number of participants with adherence data     0         158  
Week 0: Number of participants adherent to meds     NA [1]       132  
Week 12:Number of participants with adherence data     37         150  
Week 12:Number of participants adherent to meds     32         125  
Week 24:Number of participants with adherence data     32         145  
Week 24:Number of participants adherent to meds     28         118  
Week 48:Number of participants with adherence data     22         120  
Week 48:Number of participants adherent to meds     19         95  
Week 60:Number of participants with adherence data     0         91  
Week 60:Number of participants adherent to meds     NA [1]       79  
Week 72:Number of participants with adherence data     8         0  
Week 72:Number of participants adherent to meds     7         NA [1]
[1] Evaluation not specified in protocol at this timepoint.

No statistical analysis provided for Number of Participants Adherent to Study Medications



11.  Secondary:   Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL)   [ Time Frame: Arms A and B: Weeks 0, 24, 48 and 72; Arm C: Weeks 0, 12, 24, 36, 48, 60, 72, 84 ]

Measure Type Secondary
Measure Title Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL)
Measure Description A blood sample was drawn to determine the HIV-1 viral load. HIV-1 viral load was categorized as <50 copies/mL (undetectable) or >=50 copies/mL (detectable). 50 is the lower limit of detection of the assay.
Time Frame Arms A and B: Weeks 0, 24, 48 and 72; Arm C: Weeks 0, 12, 24, 36, 48, 60, 72, 84  
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 Arm A, B, and C participants

Reporting Groups
  Description
A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) At week 12 (end of the initial run-in period – Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to receive the pegylated interferon (PEG-IFN) 180 mcg weekly Arm.
B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) At week 12 (end of the initial run-in period – Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to be followed on the Observation (no treatment) Arm.
C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) At week 12 (end of initial run-in period, Step 1) participants were found to be HCV RNA negative (HCV RNA < 60 IU/mL) or had more than a 2 log decrease in HCV RNA from Baseline. Participants were assigned to remain in the Open Label (OL) part of the study continuing the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight). At the beginning of week 36, participants were retested and, if found to be HCV RNA positive (HCV RNA > 60 IU/mL), participants could be randomized to OL PEG-IFN or Observation.

Measured Values
    A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)     B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)     C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)  
Number of Participants Analyzed  
[units: participants]
  44     42     169  
Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL)  
[units: Participant]
     
Week 0: Number of participants with HIV RNA data     44     42     169  
Week 0: No. of participants with undetectable VL     32     34     146  
Week 12: Number of participants with HIV RNA data     0     0     164  
Week 12: No. of participants with undetectable VL     NA [1]   NA [1]   138  
Week 24: Number of participants with HIV RNA data     39     39     165  
Week 24: No. of participants with undetectable VL     25     25     141  
Week 36: Number of participants with HIV RNA data     0     0     160  
Week 36: No. of participants with undetectable VL     NA [1]   NA [1]   134  
Week 48: Number of participants with HIV RNA data     35     33     150  
Week 48: No. of participants with undetectable VL     24     25     125  
Week 60: Number of participants with HIV RNA data     0     0     140  
Week 60: No. of participants with undetectable VL     NA [1]   NA [1]   113  
Week 72: Number of participants with HIV RNA data     27     27     140  
Week 72: No. of participants with undetectable VL     19     20     107  
Week 84: Number of participants with HIV RNA data     0     0     136  
Week 84: No. of participants with undetectable VL     NA [1]   NA [1]   108  
[1] Test not specified in protocol at this timepoint.

No statistical analysis provided for Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL)



12.  Secondary:   Sustained Virologic Response   [ Time Frame: 24 weeks after end of treatment ]

Measure Type Secondary
Measure Title Sustained Virologic Response
Measure Description Sustained Virologic Response (SVR) was defined as undetectable HCV viral load (<60 IU/ml) 24 weeks after treatment discontinuation.
Time Frame 24 weeks after end of treatment  
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 Arm A, B and C participants

Reporting Groups
  Description
A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) At week 12 (end of the initial run-in period – Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to receive the pegylated interferon (PEG-IFN) 180 mcg weekly Arm.
B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) At week 12 (end of the initial run-in period – Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to be followed on the Observation (no treatment) Arm.
C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) At week 12 (end of initial run-in period, Step 1) participants were found to be HCV RNA negative (HCV RNA < 60 IU/mL) or had more than a 2 log decrease in HCV RNA from Baseline. Participants were assigned to remain in the Open Label (OL) part of the study continuing the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight). At the beginning of week 36, participants were retested and, if found to be HCV RNA positive (HCV RNA > 60 IU/mL), participants could be randomized to OL PEG-IFN or Observation.

Measured Values
    A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)     B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)     C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)  
Number of Participants Analyzed  
[units: participants]
  44     42     169  
Sustained Virologic Response  
[units: Participant]
     
Yes     0     0     88  
No     44     42     81  

No statistical analysis provided for Sustained Virologic Response



13.  Secondary:   Use of Antianorexia Agents, Such as Megestrol and Dronabinol   [ Time Frame: Up to 96 weeks ]

Measure Type Secondary
Measure Title Use of Antianorexia Agents, Such as Megestrol and Dronabinol
Measure Description Use of antianorexia agents, such as megestrol and dronabinol at any time after pre-assignment.
Time Frame Up to 96 weeks  
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 Arm A, B and C participants

Reporting Groups
  Description
A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) At week 12 (end of the initial run-in period – Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to receive the pegylated interferon (PEG-IFN) 180 mcg weekly Arm.
B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) At week 12 (end of the initial run-in period – Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to be followed on the Observation (no treatment) Arm.
C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) At week 12 (end of initial run-in period, Step 1) participants were found to be HCV RNA negative (HCV RNA < 60 IU/mL) or had more than a 2 log decrease in HCV RNA from Baseline. Participants were assigned to remain in the Open Label (OL) part of the study continuing the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight). At the beginning of week 36, participants were retested and, if found to be HCV RNA positive (HCV RNA > 60 IU/mL), participants could be randomized to OL PEG-IFN or Observation.

Measured Values
    A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)     B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)     C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)  
Number of Participants Analyzed  
[units: participants]
  44     42     169  
Use of Antianorexia Agents, Such as Megestrol and Dronabinol  
[units: Participant]
     
Number of participants who used megestrol     2     1     6  
Number of participants who used dronabinol     4     4     22  

No statistical analysis provided for Use of Antianorexia Agents, Such as Megestrol and Dronabinol



14.  Secondary:   Prescription as Needed of Erythropoietin (EPO), Granulocyte Colony-stimulating Factor (GCSF), and Granulocyte-monocyte Colony-stimulating Factor (GM-CSF)   [ Time Frame: At any time after pre-assignment ]

Measure Type Secondary
Measure Title Prescription as Needed of Erythropoietin (EPO), Granulocyte Colony-stimulating Factor (GCSF), and Granulocyte-monocyte Colony-stimulating Factor (GM-CSF)
Measure Description Prescription as needed of hematologic adjuvant therapies: erythropoietin (EPO), granulocyte colony-stimulating factor (GCSF), and granulocyte-monocyte colony-stimulating factor (GM-CSF) any time after pre-assignment
Time Frame At any time after pre-assignment  
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 Arm A, B and C participants

Reporting Groups
  Description
A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN) At week 12 (end of the initial run-in period – Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to receive the pegylated interferon (PEG-IFN) 180 mcg weekly Arm.
B: OL (PEG-IFN, RBV) Then OL Randomized (Observation) At week 12 (end of the initial run-in period – Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to be followed on the Observation (no treatment) Arm.
C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV) At week 12 (end of initial run-in period, Step 1) participants were found to be HCV RNA negative (HCV RNA < 60 IU/mL) or had more than a 2 log decrease in HCV RNA from Baseline. Participants were assigned to remain in the Open Label (OL) part of the study continuing the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight). At the beginning of week 36, participants were retested and, if found to be HCV RNA positive (HCV RNA > 60 IU/mL), participants could be randomized to OL PEG-IFN or Observation.

Measured Values
    A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)     B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)     C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)  
Number of Participants Analyzed  
[units: participants]
  44     42     169  
Prescription as Needed of Erythropoietin (EPO), Granulocyte Colony-stimulating Factor (GCSF), and Granulocyte-monocyte Colony-stimulating Factor (GM-CSF)  
[units: Participant]
     
Number of participants who used EPO     14     13     70  
Number of participants who used GCSF     17     8     60  
Number of participants who used GM-CSF     0     0     0  

No statistical analysis provided for Prescription as Needed of Erythropoietin (EPO), Granulocyte Colony-stimulating Factor (GCSF), and Granulocyte-monocyte Colony-stimulating Factor (GM-CSF)



15.  Secondary:   Symptom Distress   [ Time Frame: Arms A and B: at entry and weeks 12, 24, 48 and 72. Arm C: at entry and weeks 12, 24, 48, 60, 84. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

16.  Secondary:   Quality of Life   [ Time Frame: Arms A and B: at entry and weeks 12, 24, 48 and 72. Arm C: at entry and weeks 12, 24, 48, 60, 84. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

17.  Secondary:   HCV Polymorphisms   [ Time Frame: Entry and week 72 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

18.  Secondary:   HCV-specific Immune Response in Intrahepatic Lymphocytes   [ Time Frame: Entry and week 72 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

19.  Secondary:   Noninvasive Measures of Liver Fibrosis, Including Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Bilirubin, Albumin, and Protein Measurements   [ Time Frame: Entry and week 72 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

20.  Secondary:   Metabolic Parameters Including Insulin Resistance, Defined as Fasting Glucose, and Weight.   [ Time Frame: Weight: throughout study. Metabolic parameters: Arms A and B: entry and weeks 24, 48 and 72; Arm C: at entry and at weeks 12, 24, 36, 48, 60, 72 and 84. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
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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.


Results Point of Contact:  
Name/Title: Clinicaltrials.gov Coordinator
Organization: Center for Biostatistics in AIDS Research, Harvard School
e-mail: sdac.ct.gov@sdac.harvard.edu


Publications of Results:
Other Publications:

Publications automatically indexed to this study:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00078403     History of Changes
Other Study ID Numbers: A5178, 10008
Study First Received: February 24, 2004
Results First Received: November 5, 2010
Last Updated: August 13, 2014
Health Authority: United States: Food and Drug Administration