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

• Status: Unknown status
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Carlos III, Madrid
• Treatments: Epoetin Alfa; Interferon-alpha; Peginterferon alfa-2a; Ribavirin

Criteria

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