PEG-Interferon a-2b + Ribavirin for Treatment of Chronic HRN 005 Hepatitis C Infection in HIV-Infected Persons Not Previously Treated With Interferon

NCT00215891 | Completed Phase 3

• 1 other identifier: HRN 005
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: Primary To compare the sustained virologic response (SVR) of PEGIntron plus ribavirin among patients receiving 48 weeks versus 72 weeks of therapy (defined as undetectable HCV RNA level 24 weeks after discontinuing therapy). Secondary

• To evaluate the safety and tolerability PEG Intron in combination with ribavirin for treatment of Chronic Hepatitis C (CHC) infection in patients co-infected with Human Immunodeficiency Virus (HIV).
• To determine the early virologic response of patients receiving PEGIntron plus ribavirin at Treatment Week 24 Study Design: All qualifying patients will enter the treatment phase and be dosed as follows: Peginterferon a-2b 1.5mg/kg by subcutaneous route once weekly plus Ribavirin:
• 800 mg (400 mg bid) if body weight \< 65 kg
• 1000 mg (400 mg a.m. and 600 mg p.m.) if body weight \> 65 kg and \< 85 kg
• 1200 mg (600 mg bid) if body weight \> 85 kg and \< 105 kg
• 1400 mg (600 mg a.m. and 800 mg p.m.) if body weight \> 105 kg At Treatment Week 24, all participants with detectable HCV-RNA will be discontinued from treatment and followed for a Post Treatment period of 24 weeks. Participants with undetectable HCV-RNA values at Treatment Week 24 will be randomized to either:
• Group A: an additional 24 weeks of previously assigned Peginterferon a-2b + Ribavirin therapy, for a total of 48 weeks of treatment.
• Group B: an additional 48 weeks of previously assigned Peginterferon a-2b + Ribavirin therapy, for a total of 72 weeks of treatment. Study Population: 300 HIV infected adults with chronic hepatitis C infection who have not been treated previously with interferon therapy. Dosage and Administration: Peginterferon a-2b 1.5mg/kg by subcutaneous route once weekly plus Ribavirin:
• 800 mg (400 mg bid) if body weight \< 65 kg
• 1000 mg (400 mg a.m. and 600 mg p.m.) if body weight \> 65 kg and \< 85 kg
• 1200 mg (600 mg bid) if body weight \> 85 kg and \< 105 kg
• 1400 mg (600 mg a.m. and 800 mg p.m.) if body weight \> 105 kg Efficacy Evaluations: Laboratory analysis, liver biopsies, quality of life assessments, and changes in Peginterferona-2b and Ribavirin dosages will be obtained. Safety Evaluations:
• Assessment of laboratory evaluations
• vital signs
• incidence and severity of adverse experiences
• dose adjustments
• premature withdrawal for safety reasons
• progression of disease as measured by HCV viral load
• AIDS defining events

Conditions

Chronic Hepatitis C Infection in HIV-Infected Persons; HIV Infections

Keywords

Treatment Experienced

Outcome Measures

Primary Outcomes (3)

• Objectives:

• Primary

• To compare the sustained virologic response (SVR) of PEGIntron plus ribavirin among patients receiving 48 weeks versus 72 weeks of therapy (defined as undetectable HCV RNA level 24 weeks after discontinuing therapy).

Secondary Outcomes (3)

• Secondary

• · To evaluate the safety and tolerability PEG Intron in combination with ribavirin for treatment of Chronic Hepatitis C (CHC) infection in patients co-infected with Human Immunodeficiency Virus (HIV).

• · To determine the early virologic response of patients receiving PEGIntron plus ribavirin at Treatment Week 24

Interventions

PEG-Interferon a-2b + Ribavirin DRUG

Eligibility Criteria

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

You may qualify if:

• To be eligible for this trial, patients must have documentation of the following:
• Written informed consent specific to this protocol obtained prior to screening and willingness to participate in and comply with the study.
• Male and female patients \>18 years of age.
• Detectable plasma HCV-RNA by RT-PCR or other assay (bDNA).
• HCV genotype result must be available at screening (historical determinations of genotype are acceptable).
• Evidence of HIV infection (reactive HIV antibody with Western blot confirmation).
• 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

You may not qualify if:

• Patients meeting any of the following criteria are not eligible for this trial:
• Inability or unwillingness to provide written informed consent specific to this protocol or unwillingness to participate in and comply with the study.
• Previous therapy with interferon alfa.
• Women with ongoing pregnancy or breast-feeding.
• Male partners of women who are pregnant.
• Hypersensitivity to interferon or ribavirin.
• Evidence of advanced liver disease such as a history of or presence of ascites, bleeding varices, or spontaneous encephalopathy.
• Any other causes for chronic liver disease other than chronic hepatitis C.
• Hemoglobinopathies (e.g., Thalassemia) or any other cause of hemolytic anemia.
• Any known preexisting medical condition that could interfere with a patient's participation in the protocol including: CNS trauma or active seizure disorders requiring medication; poorly controlled diabetes mellitus; serious pulmonary disease; immunologically-mediated diseases; gout; or any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids.
• Patients with evidence of ischemia upon stress testing (required for patients at risk of or with a history of coronary artery disease, ECG evidence of ischemia, an arrhythmia, cardiac failure, coronary surgery, uncontrolled hypertension, angina or a myocardial infarction within 12 months).
• Active or acute HIV-related opportunistic infection.
• Evidence of severe retinopathy (e.g. CMV retinitis, macular degeneration)
• History of major organ transplantation with an existing functional graft (including Bone Marrow Transplants)
• History of any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) £6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study.

Sponsors & Collaborators

• Hepatitis Resource Network: lead
• Integrated Therapeutics Group: collaborator
• Subsidiary of Schering-Plough: collaborator

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21231-1001, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Mark Sulkowski, MD

  Hepatitis Resource Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 20, 2005
• First Posted: September 22, 2005
• Last Updated: October 25, 2005

Record last verified: 2005-09

Locations

US (1)