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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Treatment of Patients With Chronic Hepatitis C Co-infected With HIV Relapsers or Non Responders, Previous Exposed to Sub-optimal Therapies: Open, Pilot Trial

Conditions
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Chronic Hepatitis C, HIV Infections

Intervention / Treatment
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* Drug: Peginterferon alfa-2a plus ribavirin adjusted to body weight


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peginterferon alfa-2a plus ribavirin<br> | Drug: Peginterferon alfa-2a plus ribavirin adjusted to body weight<br>* PegInterferon 180 mcg/week, Adjusted body weight Ribavirin (1000 mg <75 kg, 1200 mg >75 kg)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of patients with RNA-HCV undetectable |  | 24 weeks after end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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co-infected HCV/HIV, relapsers