Pilot Study of Patients Chronic Hepatitis C in Co-infected HIV Patients Relapsers After Previous Therapies
- Conditions
- Chronic Hepatitis CHIV Infections
- Interventions
- Drug: Peginterferon alfa-2a plus ribavirin adjusted to body weight
- Registration Number
- NCT00530972
- Lead Sponsor
- Hospital Carlos III, Madrid
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Peginterferon alfa-2a plus ribavirin Peginterferon alfa-2a plus ribavirin adjusted to body weight -
- Primary Outcome Measures
Name Time Method % of patients with RNA-HCV undetectable 24 weeks after end of treatment
- Secondary Outcome Measures
Name Time Method % 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
Trial Locations
- Locations (1)
Hospital Carlos III
🇪🇸Madrid., Madrid, Spain