Study to Evaluate the Treatment for Chronic Hepatitis C With Normal Transaminases in HIV Positive Patients

Study Overview
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Brief Summary
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In the current practice patients with normal levels of ALT were not treated. However, a percentage of patients will present an advanced grade of fibrosis and cirrhosis. Another reason to treat is the similar response to the treatment than elevated ALT patients published recently in mono-infected patients. The investigators have not data concerning the evolution and response to the treatment in co-infected patients with normal ALT. In the story of treatment chronic hepatitis C of co-infected patients HCV/HIV, sometimes, it assumes a behavior similar between mono and co-infected patients and the results are different. In the case of normal ALT the investigators do not know if the natural history in co-infected patients is similar than the mono-infected patients, and also the response of the treatment. This study prospective and controls is the answer of this question. The main hypothesis is if the response of treatment in co-infected patients is not inferior than mono-infected patients. The objective is to evaluate the efficacy and safety of peginterferon alfa-2a and ribavirin in HIV positive patients with chronic hepatitis and persistently normal ALT. Every CASE (patient with normal ALT) will have a CONTROL (patient with elevated ALT), concerning genotype, gender and hospital.

Detailed Description
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The treatment of co-infected patients with normal ALT would be very important because the evolution of cirrhosis in this patients is quicker and frequently than mono-infected patients.

Official Title
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Open Multicentre, Phase IV Study to Evaluate Efficacy and Safety of Pegylated Interferon Alpha-2a (40 KD) Plus Ribavirin for Chronic Hepatitis C With Normal Transaminases in Human Immunodeficiency Virus-infected Patients

Conditions
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Chronic Hepatitis C

Intervention / Treatment
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* Drug: Peginterferon alfa-2a + ribavirin in normal ALT
* Drug: Peginterferon alfa-2a + ribavirin in elevated ALT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 18 years old Hepatitis C co infected with stable HIV-1 and normal ALT (CASE) or elevated levels of ALT (CONTROL) CD4 > 200 cel/mL Stable anti-retroviral treatment for HIV during at least, the 6 previous months to the inclusion Negative contraception test Informed consent signed Exclusion Criteria: Pregnancy Any previous treatment for CHC Any experimental treatment in the 6 previous weeks to the inclusion Cirrhosis grade B or C (Child-Pugh) Treatment with colony-stimulating factors, didanosine or zidovudine, immunomodulator therapy, isoniazid, rifampicin, … Hepatic cancer Neutrophils < 1500 cel/mL, Platelets < 70000 cel/mL, Hemoglobin < 11 g/dL (men) or < 12 g/dL (women) previous to inclusion Severe psychiatric illness background Serum creatinin > 1,5 times the upper normal limit Background of Pulmonary or Cardiovascular disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Peginterferon alfa-2a + ribavirin in normal ALT | Drug: Peginterferon alfa-2a + ribavirin in normal ALT<br>* peginterferon alfa-2a 180 mcg/weekly ribavirin 1000-1200 mg/daily<br>* Other names: Pegasys + ribavirin;|
| Active Comparator: 2<br>peginterferon alfa-2a + ribavirin in elevated ALT | Drug: Peginterferon alfa-2a + ribavirin in elevated ALT<br>* peginterferon alfa-2a 180 mcg/weekly ribavirin 1000-1200 mg/daily<br>* Other names: Pegasys + ribavirin;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic hepatitis C, normal ALT, HIV/HCV patients