Cirrhotic Hepatitis C Co-infected With Human Immunodeficiency Virus MedDRA version: 9.0 Level: LLT Classification code 10019641
Conditions
Interventions
Trade Name: PegIntron
Product Name: PEGIntron
Product Code: SCH 54031
Pharmaceutical Form: Injection*
INN or Proposed INN: peginterferon
Sponsors
Integrated Therapeutics Group, Incorporated-a subsidiary of Schering Plough
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for enrollment, subjects must meet the following inclusion criteria: 1) Display the willingness and ability to participate in the study by demonstrating full comprehension of and agreement to comply with all study procedures by signing the written informed consent. 2) =18 years but 9.0 g/dL. 14) Any serum ALT/AST liver enzyme level. 15) Serum thyroid stimulating hormone levels within normal limits, regardless of treatment with L thyroxin. 16) HbA1c50 mL/min, as assessed by the indirect calculation method (Appendix 5). 19) Demonstrate stable status of HIV infection, in the opinion of the principal investigator, (e.g., subjects who are expected to progress in the first 3 months of the study would not be appropriate for enrollment). 20) On stable antiretroviral therapy (HAART) for at least 8 weeks prior to baseline. OR 21) 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). 22) Counseled in the appropriate use of birth control while in this study, as confirmed by the principal investigator or a sub-investigator. 23) While abstinence from sexual activity is the only certain method to prevent pregnancy, female subjects of childbearing potential (includes women who are less than two years post-menopausal and wom
Exclusion criteria
Exclusion criteria: Any subject will be excluded from entry into the study if they have ANY of the following criteria: 1) Female who is pregnant, intends to become pregnant during the study or within two months after study completion, or is nursing. Male subjects whose partner wants to become pregnant. 2) Using silymarin. 3) Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, or HBeAg. 4) Any cause of liver disease other than chronic hepatitis C, including—but not limited to: a) Hemochromatosis b) Alpha-1 antitrypsin deficiency c) Wilson's disease d) Autoimmune hepatitis e) Alcoholic liver disease f) Non-alcoholic steatohepatitis (NASH) g) Drug-related liver disease 5) Suspected or having hypersensitivity to interferon. 6) 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. 7) Present with a lesion suspicious for hepatic malignancy (HCC or metastasis/metastases) on the screening imaging. 8) Any active malignant disease, suspicion, or history of malignant disease within 5 years prior to study enrollment (except for adequately treated basal cell carcinoma). 9) Known coagulation (e.g., hemophilia) or hemoglobin (e.g., thalassemia) diseases that in the opinion of the investigator presents a risk to the patient to participate in the study 10) Organ transplant, except corneal or hair transplant. 11) 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: a) Preexisting psychiatric condition, especially moderate to severe depression, or a history of severe psychiatric disorder, such as psychosis, suicidal ideation, or suicide attempts. Severe depression includes the following: i) Hospitalization for depression ii) Electroconvulsive therapy for depression, or iii) Depression causing a prolonged absence from work or significantly altering daily functions. Subjects with mild depression may be considered for entry into the study provided that a pre-treatment assessment demonstrates that the subject’s emotional status is clinically stable (either on or off drugs), in which case a management plan must be formulated for the subject; this management plan will become a part of the subject 's medical record. b) Craniocerebral trauma which is not a concussion, or active seizure disorders requiring medication c) Clinically significant ECG abnormalities and/or cardiovascular dysfunction within six previous months (e.g., angina, congestive heart failure, recent myocardial infarction, or significant arrhythmia) d) Chronic lung disease (e.g., chronic obstructive lung disease) e) Poorly controlled diabetes mellitus f) Immune-mediated disease (e.g., inflammatory bowel disease [Crohn's disease, ulcerative colitis], idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, sc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare throughout the study the efficacy of PEG-Intron® monotherapy versus standard supportive care, using the time to the first occurrence of any one of the following clinical events (death, liver decompensation, liver transplant, hepatocellular carcinoma), in the two treatment groups .; Secondary Objective: To compare the two treatment groups at the EOS: a) & b) The times and incidence to each of the following EOS: Overall mortality, Liver-related mortality, Liver decompensation, Liver transplants, Hepatocellular carcinoma (HCC) 1. To investigate the safety profile of PEG-Intron in comparison with standard supportive care. 2. To assess the effect of PEG-Intron low dose maintenance treatment on HIV infection progression as determined by: a. changes in CD4 cell count levels, b. changes in HIV RNA titers, c. HIV related infections, d. ART regimen changes. 3. Changes in serum ALT and HCV RNA. 4. Changes in Fibro Scan and APRI during the study period. 5. Changes in hepatic venous pressure gradient (HVPG) levels in a subgroup of subjects from the two treatment groups with available data. 6. Changes in proliferative histological indices and fibrotic scores in a subgroup of paired liver biopsies at the beginning and EOS. Liver biopsies will be obtained from the two treatment groups. ; Primary end point(s): The primary endpoint is to measure the time to the first occurrence of any one of the clinical end points (death, liver decompensation, liver transplant and HCC) in the two treatment groups. Secondary endpoints include: 1. To measure time to death and incidence of deaths in the two treatment groups. 2. To measure time to liver related deaths and liver related deaths incidence at the end of the study in the two treatment groups. 3. T | — |
Countries
Belgium
Outcome results
None listed