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

NCT00381017 | Withdrawn Phase 3

• 2 other identifiers: P04371EUDRACT NUMBER:2005-003876-39
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatitis C; Liver Cirrhosis; HIV Infections

Interventions

Peg interferon alpha-2b DRUG

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Integrated Therapeutics Group: collaborator

MeSH Terms

Conditions

Hepatitis C; Liver Cirrhosis; HIV Infections

Interventions

peginterferon alfa-2b

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2006
• First Posted: September 27, 2006
• Study Start: September 1, 2006
• Last Updated: August 13, 2014

Record last verified: 2014-08