Chronic Hepatitis C Clinical Trial
Official title:
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
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.
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. ;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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