Open, multicenter, phase IV study to evaluate the safety and effectiveness of peginterferon alfa-2a (40 KD) associated with ribavirin for the treatment chronic hepatitis C with persistent normal ALT in HIV coinfected patients

• Conditions: Comparate the safety and effectivenes of the treatment with peginterferon alfa-2a in combination with ribavirin between HIV/HCV coinfected patients with persistent normal ALT levels versus HIV/HCV coinfected patients with high ALT levels

• Registration Number: EUCTR2006-001243-55-ES
• Lead Sponsor: Miguel Santin Cerezales

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

>18 years
Serologic evidence of chronic hepatitis C
Detectable RNA-HCV plasmatic levels
Patients with at least 5 ALT determinations in the usual limits
Serologic evidence of HIV-1 infection: Elisa and western-blot
Stable status of HIV-1 infection.
Stable HAART treatment patients unless 6 weeks before the basal evaluation
No HAART therapy patients unless 6 weeks after the initiation of the study
Negative pregnancy test

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Child-Pugh>6
Previous or signs of decompensated hepatic disease
DdI therapy
Signs of chronic hepatic disease, not due to HCV
Hepatocarcinome documented suspect
Neutrophyles<1500
Haemoglobine<11 in women or <12 in men
Platelets<70000
Severe Psiquiatric disease
Evidence of alcohol or drugs consumption

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Comparate the safety and effectivenes of the treatment with peginterferon alfa-2a in combination with ribavirin between HIV/HCV coinfected patients with persistent normal ALT levels versus HIV/HCV coinfected patients with high ALT levels ;Secondary Objective: Knowing the hepatic histology in persistent normal ALT levels patients<br>Value the hepatic histologic response in patients with sustained viral response<br>Knowing the viral response in the 12th week depending on the basal ALT levels;Primary end point(s):