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A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Genotype 1 and Human Immunodeficiency Virus-1 (HIV-1) Co-infection

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00353418
First received: July 17, 2006
Last updated: July 30, 2010
Last verified: July 2010
Results First Received: May 14, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Hepatitis C, Chronic
Interventions: Drug: Peginterferon alfa-2a
Drug: Ribavirin

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg No text entered.
PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg No text entered.

Participant Flow:   Overall Study
    PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg   PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg
STARTED   138   277 
COMPLETED   55   119 
NOT COMPLETED   83   158 



  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.
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Reporting Groups
  Description
PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg No text entered.
PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg No text entered.
Total Total of all reporting groups

Baseline Measures
   PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg   PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 138   277   415 
Age, Customized [1] 
[Units: Participants]
     
< 65 years   134   273   407 
>=65 years   1   2   3 
[1] The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients.
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 45.2  (8.39)   45.5  (8.16)   45.4  (8.24) 
[1] The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients.
Gender [1] 
[Units: Participants]
     
Female   29   51   80 
Male   106   224   330 
[1] The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients.


  Outcome Measures
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1.  Primary:   Sustained Virological Response (SVR)   [ Time Frame: Week 72 ]

2.  Primary:   Incidence of Adverse Events, Dose Reductions and Withdrawals Due to Anemia   [ Time Frame: Up to Week 72 ]

3.  Secondary:   Virological Response at End of Treatment Period   [ Time Frame: Week 48 ]

4.  Secondary:   Virological Response at Weeks 4, 12 and 24   [ Time Frame: Weeks 4, 12 and 24 ]

5.  Secondary:   Relapse of Virological Response   [ Time Frame: Weeks 48 and 72 ]

6.  Secondary:   Rapid Virological Response (RVR) by Week 4   [ Time Frame: Week 4 ]

7.  Secondary:   Early Virological Response (EVR), Partial EVR and Complete EVR by Week 12   [ Time Frame: Week 12 ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame No text entered.
Additional Description The Safety population included all patients randomized who received at least one dose of the study medication and had at least one postbaseline safety assessment: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 274 patients.

Frequency Threshold
Threshold above which other adverse events are reported   5  

Reporting Groups
  Description
PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg No text entered.
PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg No text entered.

Other Adverse Events
    PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg   PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg
Total, other (not including serious) adverse events     
# participants affected / at risk   132/135 (97.78%)   264/274 (96.35%) 
Blood and lymphatic system disorders     
Anaemia     
# participants affected / at risk   33/135 (24.44%)   89/274 (32.48%) 
Neutropenia     
# participants affected / at risk   32/135 (23.70%)   62/274 (22.63%) 
Gastrointestinal disorders     
Nausea     
# participants affected / at risk   35/135 (25.93%)   69/274 (25.18%) 
Diarrhoea     
# participants affected / at risk   31/135 (22.96%)   60/274 (21.90%) 
Vomiting     
# participants affected / at risk   20/135 (14.81%)   25/274 (9.12%) 
Abdominal Pain     
# participants affected / at risk   8/135 (5.93%)   13/274 (4.74%) 
Dyspepsia     
# participants affected / at risk   4/135 (2.96%)   17/274 (6.20%) 
Constipation     
# participants affected / at risk   7/135 (5.19%)   10/274 (3.65%) 
General disorders     
Fatigue     
# participants affected / at risk   64/135 (47.41%)   129/274 (47.08%) 
Pyrexia     
# participants affected / at risk   36/135 (26.67%)   63/274 (22.99%) 
Chills     
# participants affected / at risk   26/135 (19.26%)   44/274 (16.06%) 
Irritability     
# participants affected / at risk   20/135 (14.81%)   32/274 (11.68%) 
Pain     
# participants affected / at risk   14/135 (10.37%)   32/274 (11.68%) 
Asthenia     
# participants affected / at risk   14/135 (10.37%)   29/274 (10.58%) 
Malaise     
# participants affected / at risk   8/135 (5.93%)   18/274 (6.57%) 
Infections and infestations     
Upper Respiratory Tract Infection     
# participants affected / at risk   8/135 (5.93%)   27/274 (9.85%) 
Urinary Tract Infection     
# participants affected / at risk   5/135 (3.70%)   16/274 (5.84%) 
Bronchitis     
# participants affected / at risk   9/135 (6.67%)   10/274 (3.65%) 
Investigations     
Weight Decreased     
# participants affected / at risk   21/135 (15.56%)   50/274 (18.25%) 
Metabolism and nutrition disorders     
Decreased Appetite     
# participants affected / at risk   34/135 (25.19%)   61/274 (22.26%) 
Musculoskeletal and connective tissue disorders     
Myalgia     
# participants affected / at risk   39/135 (28.89%)   53/274 (19.34%) 
Arthralgia     
# participants affected / at risk   23/135 (17.04%)   38/274 (13.87%) 
Back Pain     
# participants affected / at risk   16/135 (11.85%)   19/274 (6.93%) 
Muscle Spasms     
# participants affected / at risk   8/135 (5.93%)   9/274 (3.28%) 
Nervous system disorders     
Headache     
# participants affected / at risk   48/135 (35.56%)   93/274 (33.94%) 
Dizziness     
# participants affected / at risk   17/135 (12.59%)   30/274 (10.95%) 
Psychiatric disorders     
Insomnia     
# participants affected / at risk   35/135 (25.93%)   78/274 (28.47%) 
Anxiety     
# participants affected / at risk   16/135 (11.85%)   26/274 (9.49%) 
Depression     
# participants affected / at risk   30/135 (22.22%)   68/274 (24.82%) 
Respiratory, thoracic and mediastinal disorders     
Cough     
# participants affected / at risk   10/135 (7.41%)   25/274 (9.12%) 
Dyspnoea     
# participants affected / at risk   10/135 (7.41%)   25/274 (9.12%) 
Epistaxis     
# participants affected / at risk   3/135 (2.22%)   14/274 (5.11%) 
Skin and subcutaneous tissue disorders     
Rash     
# participants affected / at risk   12/135 (8.89%)   26/274 (9.49%) 
Alopecia     
# participants affected / at risk   9/135 (6.67%)   19/274 (6.93%) 
Dry Skin     
# participants affected / at risk   9/135 (6.67%)   17/274 (6.20%) 
Pruritus     
# participants affected / at risk   5/135 (3.70%)   21/274 (7.66%) 
Night Sweats     
# participants affected / at risk   7/135 (5.19%)   10/274 (3.65%) 
Hyperhidrosis     
# participants affected / at risk   7/135 (5.19%)   8/274 (2.92%) 



  Limitations and Caveats
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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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