Pilot Study of Patients Chronic Hepatitis C in Co-infected HIV Patients Relapsers After Previous Therapies
Pilot Study of Patients Chronic Hepatitis C in Co-infected HIV Patients Relapsers After Previous Therapies
To determine the efficacy and safety of Peginterferón alfa-2a (40 KD) plus Ribavirin in
 patients who have relapsed or not responded to a previous suboptimal therapy based in
 Interferon.
An important number of co-infected patients were treated suboptimally in the past with others
 ineffective therapies interferon-based.

 All co-infected patients should be an opportunity of retreatment with actually therapies.
Inclusion Criteria:

 -  Male and female patients between 18 and 65 years of age

 -  Anti-HCV positive

 -  Detectable plasma HCV-RNA

 -  Relapsers after treatment with interferon o peginterferon +/- ribavirin

 -  HIV positive

 -  CD4 >/= 200 cell

 -  Patients on clinically stable liver disease with:

 -  Hgb >/= 12 g/dL in women or 13 g/dL in men

 -  Leucocytes >/= 3000 mm3

 -  Neutrophil count (ANC) >/= 1500 cells/mm3

 -  Platelet count >/= 100.000 cells/mm3

 -  Normal prothrombin, bilirubin, albumin, creatinine and uric acid

 -  HBsAg negative

 -  With antecedents of diabetes or hypertension is necessary an previous ocular
 exploration

 Exclusion Criteria:

 -  Women with ongoing pregnancy or breast feeding

 -  Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, HBeAg

 -  Hemochromatosis

 -  Deficit of alfa-1 antitrypsin

 -  Wilson disease

 -  Alcoholic liver disease

 -  Autoimmune hepatitis

 -  Hepatitis by toxin exposures

 -  Hepatitis by obesity

 -  Hemoglobinopathy (e.g. thalassemia)

 -  History or other evidence of bleeding from esophageal varices or other conditions
 consistent with decompensated liver disease

 -  Hepatocarcinoma observed in the liver ecography.

 -  History of severe psychiatric disease, especially depression. Severe psychiatric
 disease is defined as treatment with an antidepressant medication or a major
 tranquilizer at therapeutic doses for major depression or psychosis, respectively, for
 at least 3 months at any previous time or any history of the following: a suicidal
 attempt, hospitalization for psychiatric disease, or a period of disability due to a
 psychiatric disease

 -  History of a severe seizure disorder or current anticonvulsant use

 -  History of significant cardiac disease that could be worsened by acute anemia (e.g.
 NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular
 tachyarrhythmias requiring ongoing treatment, unstable angina)

 -  Diabetes Mellitus

 -  History of immunologically mediated disease (e.g., inflammatory bowel disease,
 idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia,
 scleroderma, severe psoriasis, rheumatoid arthritis)

 -  History or other evidence of chronic pulmonary disease associated with functional
 limitation

 -  Drug use within 6 months of 1st dose and excessive alcohol consumption.

 -  Concomitant treatment with ddI

 -  Male partners of women who are pregnant