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  
Number of Participants  
[units: participants]
  138     277     415  
Age, Customized [1]
[units: Participants]
     
< 65 years     134     273     407  
>=65 years     1     2     3  
Age [1]
[units: Years]
Mean ± Standard Deviation
  45.2  ± 8.39     45.5  ± 8.16     45.4  ± 8.24  
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
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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.

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.

Serious Adverse Events
    PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg     PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg  
Total, serious adverse events      
# participants affected / at risk     21/135 (15.56%)     46/274 (16.79%)  
Blood and lymphatic system disorders      
Anaemia      
# participants affected / at risk     5/135 (3.70%)     8/274 (2.92%)  
Haemolytic Anaemia      
# participants affected / at risk     0/135 (0.00%)     2/274 (0.73%)  
Thrombocytopenia      
# participants affected / at risk     1/135 (0.74%)     1/274 (0.36%)  
Autoimmune Thrombocytopenia      
# participants affected / at risk     0/135 (0.00%)     1/274 (0.36%)  
Pancytopenia      
# participants affected / at risk     1/135 (0.74%)     0/274 (0.00%)  
Cardiac disorders      
Acute Myocardial Infarction      
# participants affected / at risk     0/135 (0.00%)     1/274 (0.36%)  
Atrial Fibrillation      
# participants affected / at risk     0/135 (0.00%)     1/274 (0.36%)  
Hypertrophic Cardiomyopathy      
# participants affected / at risk     1/135 (0.74%)     0/274 (0.00%)  
Myocardial Infarction      
# participants affected / at risk     1/135 (0.74%)     0/274 (0.00%)  
Pericarditis      
# participants affected / at risk     0/135 (0.00%)     1/274 (0.36%)  
Eye disorders      
Retinal Detachment      
# participants affected / at risk     0/135 (0.00%)     1/274 (0.36%)  
Gastrointestinal disorders      
Vomiting      
# participants affected / at risk     1/135 (0.74%)     1/274 (0.36%)  
Abdominal Pain      
# participants affected / at risk     0/135 (0.00%)     1/274 (0.36%)  
Colitis      
# participants affected / at risk     1/135 (0.74%)     0/274 (0.00%)  
Constipation      
# participants affected / at risk     0/135 (0.00%)     1/274 (0.36%)  
Oesophageal Varices Haemorrhage      
# participants affected / at risk     0/135 (0.00%)     1/274 (0.36%)  
Pancreatitis      
# participants affected / at risk     1/135 (0.74%)     0/274 (0.00%)  
Small Intestinal Obstruction      
# participants affected / at risk     0/135 (0.00%)     1/274 (0.36%)  
General disorders      
Pyrexia      
# participants affected / at risk     1/135 (0.74%)     0/274 (0.00%)  
Hepatobiliary disorders      
Cholecystitis Acute      
# participants affected / at risk     0/135 (0.00%)     1/274 (0.36%)  
Cholelithiasis      
# participants affected / at risk     0/135 (0.00%)     1/274 (0.36%)  
Infections and infestations      
Bronchitis      
# participants affected / at risk     1/135 (0.74%)     2/274 (0.73%)  
Cellulitis      
# participants affected / at risk     2/135 (1.48%)     0/274 (0.00%)  
Pneumonia      
# participants affected / at risk     1/135 (0.74%)     1/274 (0.36%)  
Pneumonia Pneumococcal      
# participants affected / at risk     1/135 (0.74%)     1/274 (0.36%)  
Staphylococcal Abscess      
# participants affected / at risk     1/135 (0.74%)     1/274 (0.36%)  
Urinary Tract Infection      
# participants affected / at risk     0/135 (0.00%)     2/274 (0.73%)  
Anal Abscess      
# participants affected / at risk     0/135 (0.00%)     1/274 (0.36%)  
Bursitis Infective      
# participants affected / at risk     0/135 (0.00%)     1/274 (0.36%)  
Carbuncle      
# participants affected / at risk     1/135 (0.74%)     0/274 (0.00%)  
Gangrene      
# participants affected / at risk     0/135 (0.00%)     1/274 (0.36%)  
Gastroenteritis      
# participants affected / at risk     1/135 (0.74%)     0/274 (0.00%)  
Gastroenteritis Viral      
# participants affected / at risk     0/135 (0.00%)     1/274 (0.36%)  
Herpes Zoster      
# participants affected / at risk     1/135 (0.74%)     0/274 (0.00%)  
Infected Skin Ulcer      
# participants affected / at risk     1/135 (0.74%)     0/274 (0.00%)  
Influenza      
# participants affected / at risk     0/135 (0.00%)     1/274 (0.36%)  
Pneumococcal Bacteraemia      
# participants affected / at risk     0/135 (0.00%)     1/274 (0.36%)  
Sepsis      
# participants affected / at risk     0/135 (0.00%)     1/274 (0.36%)  
Subcutaneous Abscess      
# participants affected / at risk     0/135 (0.00%)     1/274 (0.36%)  
Subdiaphragmatic Abscess      
# participants affected / at risk     0/135 (0.00%)     1/274 (0.36%)  
Wound Infection      
# participants affected / at risk     0/135 (0.00%)     1/274 (0.36%)  
Injury, poisoning and procedural complications      
Accidental Overdose      
# participants affected / at risk     1/135 (0.74%)     0/274 (0.00%)  
Ankle Fracture      
# participants affected / at risk     0/135 (0.00%)     1/274 (0.36%)  
Multiple Injuries      
# participants affected / at risk     0/135 (0.00%)     1/274 (0.36%)  
Splenic Injury      
# participants affected / at risk     0/135 (0.00%)     1/274 (0.36%)  
Metabolism and nutrition disorders      
Abnormal Loss of Weight      
# participants affected / at risk     0/135 (0.00%)     2/274 (0.73%)  
Dehydration      
# participants affected / at risk     1/135 (0.74%)     1/274 (0.36%)  
Hyperglycaemia      
# participants affected / at risk     0/135 (0.00%)     1/274 (0.36%)  
Hyponatraemia      
# participants affected / at risk     0/135 (0.00%)     1/274 (0.36%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Benign Lung Neoplasm      
# participants affected / at risk     0/135 (0.00%)     1/274 (0.36%)  
Hepatic Neoplasm Malignant      
# participants affected / at risk     0/135 (0.00%)     1/274 (0.36%)  
Lung Adenocarcinoma      
# participants affected / at risk     0/135 (0.00%)     1/274 (0.36%)  
Nervous system disorders      
Brain Stem Ischaemia      
# participants affected / at risk     0/135 (0.00%)     1/274 (0.36%)  
Convulsion      
# participants affected / at risk     1/135 (0.74%)     0/274 (0.00%)  
Optic Neuritis      
# participants affected / at risk     1/135 (0.74%)     0/274 (0.00%)  
Psychiatric disorders      
Depression      
# participants affected / at risk     1/135 (0.74%)     2/274 (0.73%)  
Completed Suicide      
# participants affected / at risk     0/135 (0.00%)     1/274 (0.36%)  
Substance Abuse      
# participants affected / at risk     1/135 (0.74%)     0/274 (0.00%)  
Suicidal Ideation      
# participants affected / at risk     0/135 (0.00%)     1/274 (0.36%)  
Suicide Attempt      
# participants affected / at risk     1/135 (0.74%)     0/274 (0.00%)  
Reproductive system and breast disorders      
Epididymitis      
# participants affected / at risk     0/135 (0.00%)     1/274 (0.36%)  
Prostatitis      
# participants affected / at risk     0/135 (0.00%)     1/274 (0.36%)  
Respiratory, thoracic and mediastinal disorders      
Chronic Obstructive Pulmonary Disease      
# participants affected / at risk     2/135 (1.48%)     0/274 (0.00%)  
Asthma      
# participants affected / at risk     0/135 (0.00%)     1/274 (0.36%)  
Dyspnoea      
# participants affected / at risk     0/135 (0.00%)     1/274 (0.36%)  
Haemoptysis      
# participants affected / at risk     0/135 (0.00%)     1/274 (0.36%)  
Respiratory Failure      
# participants affected / at risk     0/135 (0.00%)     1/274 (0.36%)  
Vascular disorders      
Orthostatic Hypotension      
# participants affected / at risk     0/135 (0.00%)     1/274 (0.36%)  




  Other Adverse Events


  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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