Phase IV Study to Evaluate the Efficacy/Safety to Extend Treatment and High Dose of Ribavirin in co-Infected Patients (PERICO)

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring high dose of ribavirin, extend treatment duration, tailoring treatment Read More

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