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

HIV Infections Clinical Trial

Official title:

A Randomized, Open-label, Multi-center, Phase 3, 2-arm Study Evaluating the Efficacy and Safety of Peg Interferon Alfa-2b Low-dose Maintenance Monotherapy Versus Standard Supportive Care in Patients With Cirrhotic Hepatitis C Co-infected With Human Immunodeficiency Virus - The ENDURE Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00381017
• Other study ID #: P04371
• Secondary ID: EUDRACT NUMBER:2
• Status: Withdrawn
• Phase: Phase 3
• First received: September 26, 2006
• Last updated: August 11, 2014
• Start date: September 2006

Study information

• Verified date: August 2014
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• HIV Infections
• Liver Cirrhosis

Intervention

Drug:
• Peg interferon alpha-2b

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.	Integrated Therapeutics Group