HRN 004- Peginterferon a-2a Plus Ribavirin for Chronic Hepatitis C Infection in HIV Infected Persons Who Have Failed to Achieve a Sustained Virologic Response Following Previous Interferon Therapy

Inclusion Criteria

• •To be eligible for this trial, patients must have documentation of the following:
• •4.2.1 Written informed consent specific to this protocol obtained prior to screening and willingness to participate in and comply with the study.
• •4.2.2 Male and female patients \>18 years of age.
• •4.2.3 Detectable plasma HCV-RNA by RT-PCR or other assay (bDNA).
• •4.2.4 HCV genotype result must be available at screening (historical determinations of genotype are acceptable).
• •4.2.5 Evidence of HIV infection (reactive HIV antibody with Western blot confirmation).
• •4.2.6 Chronic liver disease consistent with chronic hepatitis C infection on a biopsy, as judged by a qualified pathologist, obtained within the past 18 months. For all participants, both the liver biopsy report and the biopsy specimen (both an H and E slide and a Trichrome slide) must be made available for review by the central pathologist.
• •4.2.7 Previous antiviral treatment with alfa interferon monotherapy or, or interferon alfa plus ribavirin combination therapy administered for at least 12 weeks with the failure to obtain a sustained virologic response.
• •4.2.8 No therapy with interferon or interferon plus ribavirin or other specific anti-HCV medications within 4 weeks of the screening.
• •4.2.9 Compensated liver disease with the following laboratory parameters at screening (results within 1 month of screening):
• •Hemoglobin values of ³ 11 gm/dL
• •WBC ³ 3,000/mm3
• •Neutrophil count ³1,250/mm3
• •Platelets ³ 70,000/mm3
• •Prothrombin time £ 3 seconds prolonged compared to control, or equivalent INR ratio
• •Bilirubin within 20% of the upper limit of normal (unless non-hepatitis related factors such as Gilbert's disease or the use of indinivir explains an indirect bilirubin rise).
• •Albumin ³ 3.0 g/dL
• •Serum creatinine £ 1.4 mg/dL
• •Fasting blood sugar £ 115 mg/dL for non-diabetic patients
• •Hemoglobin A1C £ 8.5% for diabetic patients (whether on medication and/or diet controlled)
• •4.2.10 Thyroid Stimulating Hormone (TSH) within normal limits or thyroid disease under clinical control (within 3 months of screening)
• •4.2.11 Alpha-fetoprotein (AFP) value within normal limits obtained within the prior year. For patients with results above the upper limit of normal but \< 100 ng/mL both of the following are required:
• •Alpha-fetoprotein value \< 100 ng/mL obtained within 3 months prior to entry AND
• •Ultrasound obtained within 3 months prior to entry that is negative for evidence of hepatocellular carcinoma.
• •4.2.12 CD4 T cell count and HIV RNA level (by RT-PCR) within 4 weeks of screening:
• •CD4 \<100 Eligible with HIV RNA \<25,000 by RT-PCR
• •CD4 \> 100 - Eligible with any HIV RNA level by RT-PCR
• •4.2.13 Stable antiretroviral regimen of FDA-approved agents for at least 4 weeks prior to baseline or has taken no antiretroviral agents within 4 weeks prior to baseline.
• •4.2.14 Reconfirmation and documentation that all sexually active female patients of childbearing potential are practicing adequate contraception (intrauterine device, oral contraceptives, progesterone implanted rods \[Norplant\], medroxyprogesterone acetate \[Depo-Provera\], surgical sterilization, barrier method \[diaphragm + spermicide\], or monogamous relationship with a male partner who has had a vasectomy or is using a condom + spermicide) during the treatment period and for 6 months after discontinuation of therapy. Female patients must not breast feed during the treatment period and for 6 months after discontinuation of therapy. A urine pregnancy test obtained at entry prior to the initiation of treatment must be negative.
• •4.2.15 Reconfirmation and documentation that sexually active male patients are practicing acceptable methods of contraception (vasectomy, use of a condom + spermicide, monogamous relationship with a female partner who practices an acceptable method of contraception) during the treatment period and for 6 months after discontinuation of therapy.
• •4.2.16 Anyone at high risk of coronary artery disease should have a stress test performed prior to entry. This would include, but not be limited to, patients over age 55 who have a history of ischemia or who have a significant history of hypertension, diabetes mellitus, obesity, smoking and/or strong family history of coronary artery disease. Patients with evidence of ischemia on resting or stress EKG, or a history of an arrhythmia, angina or a myocardial infarction within 12 months must be excluded.