EUCTR2006-001243-55-ES
Active, not recruiting
Not Applicable
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
Miguel Santin Cerezales0 sites230 target enrollmentJune 14, 2006
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- 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
- Sponsor
- Miguel Santin Cerezales
- Enrollment
- 230
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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:
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
Outcomes
Primary Outcomes
Not specified
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