Chronic Hepatitis C | Phase IV Study to Evaluate the Efficacy/Safety to Extend Treatment and High Dose of Ribavirin in co-Infected Patients
Chronic Hepatitis C research study
What is the primary objective of this study?
To compare the sustained virological response (SVR = ribonucleic acid (RNA) - hepatitis C virus (HCV) undetectable at week 24 before end the treatment) in chronic hepatitis C patients genotype 1-4 co-infected with HIV-HCV, treated with Peginterferón alfa-2a (40 KD) 180 µg/week and Ribavirin (2000 mg/day during 4 weeks, follow of 1000-1200 mg/day, according to body weight); versus Peginterferón alfa-2a (40 KD) 180 μg/week and Ribavirin (1000-1200 mg/day, according to body weight). To evaluate the impact to extend the treatment with Peginterferon alfa-2a and Ribavirin to week 72, in SVR of these patients with genotypes 1-4 without rapid virological response (RVR = RNA - HCV undetectable at 4 week).
Who is eligible to participate?
Inclusion Criteria: - Male and female patients > 18 years of age - Serologic evidence of anti-HCV - Detectable plasma HCV-RNA - Serologic evidence of HIV-1 infection - CD4 cell count >/= 250 cell/mm3 - Stable status of HIV-1 infection in the opinion of the investigator - Patients on stable antiretroviral therapy (HAART) for at least 6 weeks prior to baseline whose HAART regimen (drugs and dosage) is expected to remain unaltered for the first 6 weeks of this study - Patients who have not been on HAART for at least 6 weeks prior to randomization who are willing to delay initiation of HAART therapy for at least 6 weeks - Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug - Willingness to give written informed consent Exclusion Criteria: - Women with ongoing pregnancy or breast feeding - Male partners of women who are pregnant - IFN/ribavirin therapy at any previous time - Child Pugh > 6 (Child Pugh B or C) - History or conditions consistent with decompensated liver disease - Any investigational drug 6 weeks prior to the first dose of study drug (expanded access programs for HIV treatment are allowed) - Patients treated with didanosine and/or zidovudine - Positive test at anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, HBeAg - History or other evidence of a medical condition associated with chronic liver disease other than HCV - Hepatocarcinoma observed in the liver ecography - Serum concentrations of ceruloplasmin or alfa1-antitrypsin at screening consistent with an increased risk of metabolic liver disease - Active HIV-related opportunistic infection and/or malignancy requiring acute systemic therapy - Absolute neutrophil count (ANC) < 1500 cells/mm3 - Hgb < 11 g/dL in women or 12 g/dL in men or any patient for whom anemia would be medically problematic - Hemoglobinopathy or any other cause of or tendency for hemolysis - Platelet count < 50,000 cells/mm3 - History of G-CSF, GM-CSF or epo treatment during 3 months prior to the first dose of study drug - Serum creatinine level > 1.5 times the upper limit of normal at screening - History of severe psychiatric disease, especially depression - History of a severe seizure disorder or current anticonvulsant use - History of immunologically mediated disease - History or other evidence of chronic pulmonary disease associated with functional limitation - History of significant cardiac disease that could be worsened by acute anemia - History of thyroid disease poorly controlled on prescribed medications - Evidence of severe retinopathy - History of major organ transplantation with an existing functional graft - History or other evidence of severe illness, malignancy or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study - History of any systemic anti-neoplastic or immunomodulatory treatment 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 - Concomitant medication with rifampin/rifampicin, rifabutin, pyrazinamide, isoniazid, gancyclovir, thalidomide, oxymetholone, immunomodulatory treatments and systemic antiviral agents as adjuvant therapy for CHC - Drug use within 6 months of 1st dose and excessive alcohol consumption
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Chronic Hepatitis C
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Peginterferon alfa-2aPeginterferon alfa-2a 180 mcg/week
Drug:epoetin betaepoetin beta 450 UI/week
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
1Peginterferon alfa-2a 180 mcg/week + ribavirin 2000 mg/day + epoetin beta 450 UI/week
2Peginterferon alfa-2a 180 mcg/week + ribavirin 1000-1200 mg/day
Start Date: June 2007
Completed Date: February 2010
Phase: Phase 4
Primary Outcome: % patients with RNA-HCV < 50 UI/ml
Secondary Outcome: % patients with RNA-HCV < 50 UI/ml
Study sponsors, principal investigator, and references
Principal Investigator: Vicente Soriano, Dr
Lead Sponsor: Hospital Carlos III, Madrid