CONTRAOpen 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
Peginterferon alfa-2a + ribavirin in normal ALT
+ Peginterferon alfa-2a + ribavirin in elevated ALT
Blood-Borne Infections+14
+ Chronic Disease
+ Communicable Diseases
Treatment Study
Summary
Study start date: September 1, 2006
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.80 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 18 locations
Hospital del Mar
Barcelona, SpainHospital Santa Creu i Sant Pau
Barcelona, SpainHospital Clinic
Barcelona, Spain