Effects of Low-dose Maintenance Peg Interferon Alfa-2b Therapy Versus Supportive Care in Patients With Cirrhotic Hepatitis C With HIV (Study P04371)

Launched by MERCK SHARP & DOHME LLC · Sep 26, 2006

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Eligibility criteria

• Inclusion Criteria:
• • Age at least 18 years but \< 70 years, of either sex or any race.
• • Detectable plasma hepatitis C virus (HCV) RNA (all genotypes of HCV are permitted).
• • Cirrhosis of the liver within the last five years.
• • Compensated liver disease (Child-Pugh \<8 with hepatic encephalopathy \<= 1.
• • No evidence of hepatocellular carcinoma (HCC) and a serum alpha fetoprotein (AFP) \<100 ng/mL within two months of randomization/study enrollment.
• • Varices results via endoscopy within the last six months or at time of screening.
• • Serologic evidence of human immunodeficiency virus-1.
• • CD4 cell count \>=100 /µL.
• • Platelet number of at least 50000 mm\*\*3.
• • Neutrophil count of at least 750 mm\*\*3.
• • Hemoglobin of \>9.0 mg%.
• • Serum thyroid stimulating hormone levels within normal limits, regardless of treatment with L thyroxin.
• • Hemoglobin A1c (HbA1c)\<8.5%, to demonstrate controlled diabetes, if applicable.
• • Written clearance from an ophthalmologist must be presented for subjects with a history of hypertension or diabetes prior to treatment start.
• • Creatinine clearance \>50 mL/min, as assessed by the indirect calculation method.
• • Demonstrate stable status of HIV-1 infection.
• • On stable antiretroviral therapy (HAART) for at least 6 weeks prior to baseline, with the expectation of their HAART regimen (drugs and dosage) remaining unaltered for the first 8 weeks of the study OR
• • Willing to delay initiation of HAART therapy for at least 6 weeks (for subjects who have not been on HAART for at least 8 weeks prior to randomization). "Structured treatment interruptions" will be permitted during the study.
• • Counseled in the appropriate use of birth control while in this study, as confirmed by the principal investigator or a sub-investigator.
• • Free of any clinically significant disease (other than HCV and HIV) that would interfere with study evaluations.
• Exclusion Criteria:
• • Female who is pregnant, intends to become pregnant during the study or within two months after study completion, or is nursing. Male subject whose partner wants to become pregnant.
• • Using silymarin.
• • Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, or HBeAg.
• • Any cause of liver disease other than chronic hepatitis C.
• • Suspected or having hypersensitivity to interferon.
• • History of liver decompensation status or other evidence of bleeding from esophageal varices, signs of current bleeding, significant ascites, hepatic encephalopathy, jaundice or other conditions consistent with decompensated liver disease.
• • Present with a lesion suspicious for hepatic malignancy on the screening imaging.
• • Any active malignant disease, suspicion, or history of malignant disease within 5 years prior to study enrollment (except for adequately treated basal cell carcinoma).
• • Known coagulation or hemoglobin diseases.
• • Organ transplant, except corneal or hair transplant.
• • Any known preexisting medical condition that, in the investigator's opinion, could interfere with the subject's participation in and completion of the study, such as major depressive disorder.
• • Active HIV-related opportunistic infection and/or malignancy requiring systemic therapy.
• • Evidence of known severe retinopathy.
• • Subject has not observed the designated washout periods for any of the prohibited medications.
• • Participating in any other hepatitis C clinical study.