Chronic Hepatitis C Clinical Trial
— CONTRAOfficial 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
Verified date | September 2012 |
Source | Hospital Universitari de Bellvitge |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Spanish Agency of Medicines |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | June 2011 |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Hospital de Cruces | Baracaldo | Vizcaya |
Spain | Hospital Clinic | Barcelona | |
Spain | Hospital del Mar | Barcelona | |
Spain | Hospital Santa Creu i Sant Pau | Barcelona | |
Spain | Consorci Sanitari Integral | Hospitalet | Barcelona |
Spain | Hospital Universitari of Bellvitge | Hospitalet | Barcelona |
Spain | Hospital San Jorge | Huesca | |
Spain | Hospital 12 de Octubre | Madrid | |
Spain | Hospital Clínico San Carlos | Madrid | |
Spain | Hospital de la Princesa | Madrid | |
Spain | Hospital Ramón y Cajal | Madrid | |
Spain | Hospital General de Mataró | Mataró | Barcelona |
Spain | Hospital de Donostia | San Sebastián | Guipúzcoa |
Spain | Hospital Joan XXIII | Tarragona | |
Spain | Consorci Sanitari de Terrassa | Terrassa | Barcelona |
Spain | Hospital Xeral-Cíes | Vigo | Pontevedra |
Spain | Hospital de Txagorritxu | Vitoria | Alava |
Spain | Hospital Clínico Lozano Blesa | Zaragoza |
Lead Sponsor | Collaborator |
---|---|
Miguel Santin |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | % patients with RNA-HCV negative | 24 weeks after treatment | No |
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