Study to Evaluate the Treatment for Chronic Hepatitis C With Normal Transaminases in HIV Positive Patients
NCT ID: NCT01684787
Last Updated: 2012-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
80 participants
INTERVENTIONAL
2006-09-30
2011-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Peginterferon alfa-2a + ribavirin in normal ALT
Peginterferon alfa-2a + ribavirin in normal ALT
peginterferon alfa-2a 180 mcg/weekly ribavirin 1000-1200 mg/daily
2
peginterferon alfa-2a + ribavirin in elevated ALT
Peginterferon alfa-2a + ribavirin in elevated ALT
peginterferon alfa-2a 180 mcg/weekly ribavirin 1000-1200 mg/daily
Interventions
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Peginterferon alfa-2a + ribavirin in normal ALT
peginterferon alfa-2a 180 mcg/weekly ribavirin 1000-1200 mg/daily
Peginterferon alfa-2a + ribavirin in elevated ALT
peginterferon alfa-2a 180 mcg/weekly ribavirin 1000-1200 mg/daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Miguel Santin
OTHER
Responsible Party
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Miguel Santin
Dr
Principal Investigators
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Miguel Santin, Dr
Role: STUDY_CHAIR
Hospital Universitari of Bellvitge
Locations
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Hospital de Txagorritxu
Vitoria-Gasteiz, Alava, Spain
Hospital del Mar
Barcelona, Barcelona, Spain
Hospital Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
Hospital Clinic
Barcelona, Barcelona, Spain
Consorci Sanitari Integral
Hospitalet, Barcelona, Spain
Hospital Universitari of Bellvitge
Hospitalet, Barcelona, Spain
Hospital General de Mataró
Mataró, Barcelona, Spain
Consorci Sanitari de Terrassa
Terrassa, Barcelona, Spain
Hospital de Donostia
San Sebastián, Guipúzcoa, Spain
Hospital San Jorge
Huesca, Huesca, Spain
Hospital de la Princesa
Madrid, Madrid, Spain
Hospital Ramón y Cajal
Madrid, Madrid, Spain
Hospital Clínico San Carlos
Madrid, Madrid, Spain
Hospital 12 de Octubre
Madrid, Madrid, Spain
Hospital Xeral-Cíes
Vigo, Pontevedra, Spain
Hospital Joan XXIII
Tarragona, Tarragona, Spain
Hospital de Cruces
Barakaldo, Vizcaya, Spain
Hospital Clínico Lozano Blesa
Zaragoza, Zaragoza, Spain
Countries
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Other Identifiers
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Miguel Santín
Identifier Type: -
Identifier Source: org_study_id