Pilot Study of Patients Chronic Hepatitis C in Co-infected HIV Patients Relapsers After Previous Therapies

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

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

Criteria

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