Hepatitis C, HIV Infections, Liver Cirrhosis
Conditions
Brief summary
This is a Phase 3b, randomized, open-label, parallel-group, multi-center, multi-national study of low-dose maintenance Peg interferon alpha-2b (Peg-Intron®) in subjects with human immunodeficiency virus-hepatitis C virus (HIV-HCV) co-infection. The primary objective is to compare at end of study the efficacy of Peg-Intron® monotherapy (0.5 µg/kg subcutaneously once weekly for 24-36 months) versus standard supportive care, using the time to any of the following clinical events (death, decompensation, liver transplant, hepatocellular carcinoma \[HCC\]) as endpoints.
Interventions
DRUGPeg interferon alpha-2b
Sponsors
Integrated Therapeutics Group
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
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.
Outcome results
None listed