Efficacy and Safety of PegIntron Plus Ribavirin for Treatment of Chronic Hepatitis C in HIV-Infected Subjects (Study P04469)(TERMINATED)
Condition: Hepatitis C, Chronic; Hepacivirus; HIV Infections
MeSH terms: Infections; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Peginterferon alfa-2b (SCH 054031); Ribavirin (SCH 018908)
Intervention description: Subjects will be given peginterferon alfa-2b (PEG-IFN) subcutaneously, at a dose of 1.5 ug/kg weekly. Treatment duration will be 48 weeks for subjects with Hepatitis C Virus (HCV) genotype 1 and 24 weeks for subjects with HCV genotype 2 or 3 and baseline Hepatitis C Virus-ribonucleic acid (HCV-RNA) below 800,000 IU/mL.; Subjects will be given ribavirin 800 mg/day orally(PO) when body weight is <65 kg, 1000 mg/day when body weight is between 65 kg and 85 kg, and 1200 mg/day when body weight is >85 kg. Treatment duration will be 48 weeks for subjects with HCV genotype 1 and 24 weeks for subjects with HCV genotype 2 or 3 and baseline HCV-RNA below 800,000 IU/mL.
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: HIV

Summary:

      In this study, adult Indonesian subjects with human immunodeficiency virus (HIV) coinfected
      with chronic hepatitis C (CHC) will be given peginterferon alfa-2b (PEG-IFN) plus ribavirin
      (RBV) combination therapy. The efficacy rate (sustained virologic response, end of treatment
      virologic response, and sustained biochemical response), the subject morbidity rate as caused
      by other opportunistic infection (eg, bacterial pneumonia, tuberculosis, and other bacterial
      infection), and the safety and tolerability of this combination therapy will be examined.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previously untreated chronic hepatitis C with HCV-RNA positive in plasma.

          -  Must have finished the detoxification phase of a drug rehabilitation program and
             abstained for at least 6 weeks from using abused substance (alcohol, I.V. drugs and
             inhaled drugs) before starting therapy.

          -  Liver transaminases (alanine aminotransferase [ALT]) 1.5-fold above the upper limit of
             normal.

          -  Controlled HIV infection with a viral load <10,000 copies/mL and a CD4 cell (T-cell)
             count >200 x 10^6 cells/L, in response to a stable antiretroviral treatment (ART) or
             without ART if it is not required.

          -  Compensated liver disease with protocol-specified minimum hematologic, biochemical,
             and serologic criteria at the Entry visit.

          -  Alpha-fetoprotein value within normal limits obtained within one year prior to entry.
             Results above the upper limit of normal but <=50 ng/mL require both of the following:
             Alpha-fetoprotein value <=50 ng/mL obtained within 3 months prior to entry in the
             study and Ultrasound obtained within 3 months prior to entry in the study or that is
             negative for evidence of hepatocellular carcinoma.

          -  Liver biopsy (optional) within 12 months prior to study entry with a pathology report
             confirming that the histologic diagnosis is consistent with chronic hepatitis.

          -  Women of childbearing potential must be using an acceptable method of birth control or
             be surgically sterilized.

          -  Reconfirmation that sexually active males must be practicing acceptable methods of
             contraception during the treatment period and for 6 months after discontinuation of
             therapy.

          -  Subjects must be free of any clinically significant diseases other than hepatitis or
             HIV infection that would interfere with study evaluations.

        Exclusion Criteria:

          -  Suspected hypersensitivity to interferon, PEG-interferon, or ribavirin.

          -  HIV therapy using didanosine (ddI) and stavudine (d4T) in their HIV medications, due
             to the potentiality of the resulting lactic acidosis.

          -  Participation in any other clinical trial within 30 days of entry to this protocol.

          -  Treatment with any investigational drug within 30 days of entry to this protocol.

          -  Subjects with organ transplants other than cornea and hair transplant.

          -  Any cause for the liver disease based on subject history and biopsy (where applicable)
             other than chronic hepatitis C, including but not limited to coinfection with
             hepatitis B virus (HBV); hemochromatosis (iron deposition >2+ in liver parenchyma);
             alpha-1 antitrypsin deficiency; Wilson's disease; autoimmune hepatitis; alcoholic
             liver disease; obesity-induced liver disease.

          -  Hemophilia or any other condition that would prevent the subject from having a liver
             biopsy, including anticoagulant therapy.

          -  Hemoglobinopathies (eg, Thalassemia)

          -  Evidence of advanced liver disease such as history or presence of ascites, bleeding
             varices, and encephalopathy.

          -  Any known preexisting medical condition that could interfere with the subject's
             participation in and completion of the protocol such as preexisting psychiatric
             condition, especially severe depression, or a history of severe psychiatric disorder.

          -  Significant cardiovascular dysfunction within the past 6 months (eg, angina,
             congestive heart failure, recent myocardial infarction, severe hypertension, or
             significant arrhythmia). Subjects with electrocardiogram (ECG) showing clinically
             significant abnormalities.

          -  Poorly controlled diabetes mellitus.

          -  Chronic pulmonary disease (eg, chronic obstructive pulmonary disease).

          -  Immunologically mediated disease.

          -  Any medical condition requiring, or likely to require during the course of the study,
             chronic systemic administration of steroids.

          -  Clinical gout.

          -  Clinically significant retinal abnormalities.

          -  Alcohol consumption of >20 gr/day.

          -  Women who are pregnant or nursing.

          -  Subjects who have not observed the designated washout periods for any of the
             prohibited medications.