Chronic Hepatitis C, HIV Infections
Conditions
Keywords
co-infected HCV/HIV, relapsers
Brief 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.
Detailed description
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.
Interventions
DRUGPeginterferon alfa-2a plus ribavirin adjusted to body weight
PegInterferon 180 mcg/week, Adjusted body weight Ribavirin (1000 mg \<75 kg, 1200 mg \>75 kg)
Sponsors
Hospital Carlos III, Madrid
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| % of patients with RNA-HCV undetectable | 24 weeks after end of treatment |
Secondary
| Measure | Time frame |
|---|---|
| % of patients with RNA-HCV undetectable at different moments of the treatment according genotype, viremia, liver fibrosis, number of CD4 cells and previous therapy | At weeks 4, 12, 24 and 48 on treatment |
| Ribavirin levels | At weeks 4, 12, 24 and 48 on treatment |
| Impact of dose reduction peg-interferon and/or ribavirin | At weeks 4, 12, 24 and 48 on treatment |
Countries
Spain
Outcome results
None listed