Retreatment With High Doses of pegIFN Alfa-2a and Ribavirin of Previous Nonresponders HIV-coinfected Patients With Cirrhosis Due to HCV 1-4
Sociedad Andaluza de Enfermedades Infecciosas
Information provided by (Responsible Party)
Antonio Rivero, Sociedad Andaluza de Enfermedades Infecciosas
First received: October 29, 2009
Last updated: December 28, 2011
Last Verified: December 2011
History of Changes
Objective: To evaluate the efficacy and safety of high doses of both peginterferon-alfa 2a
(360 ug per week) plus ribavirin (800 mg b.i.d.) in HIV-infected patients with compensated
liver cirrhosis by HCV genotype 1 or 4 without previous virological response(*) to a standard
dose treatment of both drugs.
(*) Non previous virological response: no decrease of plasma RNA-HCV at least 2 log10 after 12 weeks in treatment or breakthrough viremia while on treatment.
Additionally, this study will evaluated the influence of simultaneous peginterferon-alfa 2a and ribavirin plasma concentrations on early viral response (EVR) and sustained viral response (SVR) in these patients.
Method: Pilot clinical trial, phase II-III, open labeled multicenter in which patients from several hospitals of the Servicio Andaluz de Salud will be enrolled.
The usual clinical and analytical follow up will be performed but additional blood samples will be obtained for determination of interferon and ribavirin plasma levels. The primary end point will be a sustained virologic response (defined as an undetectable serum HCV-RNA after 24 weeks after the cessation of treatment). Likewise, rapid virological response (at 4 weeks of treatment), early virological response (at 12 weeks), and end of treatment response rates will be evaluated as well as their relationships with the plasma interferon an ribavirin concentrations determined by ELISA and HPLC, respectively. The safety and tolerability of the studied medications will be evaluated by means of clinical adverse events, physical examination and laboratory results. The evolution of liver fibrosis will be evaluated comparing the basal and end of treatment results of transient elastometry.
Hepatitis C Virus
Drug : Pegylated interferon alfa-2a and Ribavirin
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Efficacy of High Doses of Both Pegylated Interferon Alfa-2a and Ribavirin for Retreatment of HIV-coinfected Patients With Liver Cirrhosis Due to HCV Genotype 1 or 4 Nonresponders to Previous Standard Therapy.|
Further study details as provided by Antonio Rivero, Sociedad Andaluza de Enfermedades Infecciosas:
Primary Outcome Measures
- Sustained viral response (undetectable serum HCV-RNA) [ Time Frame: Throughout treatment and 24 weeks after finishing it ]
- Relationships between the plasma interferon an ribavirin concentrations and efficacy [ Time Frame: Throughout treatment and 24 weeks after finishing it. ]
- safety and tolerability of the studied medications [ Time Frame: Throughout treatment and 24 weeks after finishing it ]
- The evolution of liver fibrosis will be evaluated comparing the basal and end of treatment results of transient elastometry [ Time Frame: baseline and after finishing treatment ]
|Study Start Date:||October 2009|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
PegIFN alfa-2a and Ribavirin
HIV-coinfected patients with compensated cirrhosis by hepatitis C virus, genotype 1 or 4.
Pegylated interferon alfa-2a and Ribavirin
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Age older than 18 years
- HIV-infected patients with compensated liver cirrhosis by HCV genotype 1 or 4 without previous virological response(*) to a standard dose treatment of both drugs.
- Women of child-bearing age: negative pregnancy test
- Ability to understand and sign a written consent form
- HCV genotypes different to 1 or 4
- Acute or chronic hepatitis B infection (positivity for hepatitis B surface antigen or plasma DNA) or other concomitant causes of liver disease
- Pregnancy or breast feeding.
- Decompensated liver disease at baseline.
- Neutropenia <1000/uL, anemia <100 g/L or thrombocytopenia <20.000/uL.
- Creatinine clearance < 50 mL/min.
- Concomitant treatment with immunomodulators or zidovudine, didanosine or stavudine.
- Organ or bone marrow transplantation
- Current alcoholism or iv drug abuse. Methadone is allowed.
- Current neoplasm and/or anti-tumor chemotherapy or immunomodulators
- Psychosis or uncontrolled clinical depression
- Auto-immune disease, including auto-immune hepatitis
- History of significant cardiovascular disease (NYHA III-IV) including but not limited to uncontrolled hypertension, angina pectoris, myocardial infarction, coronary artery surgery and congestive heart failure.
- Thyroid dysfunction.
- Clinically significant retinal abnormalities
- Inability to understand and sign a written consent form
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01006031
Locations Show More
|Hospital Universitario Reina Sofía|
|Hospitales Universitarios Virgen del Rocío|
|Hospital Universitario de Valme|
|Hospital Universitario Virgen Macarena|
Sponsors and CollaboratorsSociedad Andaluza de Enfermedades Infecciosas
|Study Director:||Luis F Lopez-Cortes, MD, PhD||Instituto de Biomedicina de Sevilla. Hospitales Universitarios Virgen del Rocío|
|Principal Investigator:||Luis F Lopez-Cortes, MD, PhD||Instituto de Biomedicina de Sevilla. Hospitales Universitarios Virgen del Rocio|
|Principal Investigator:||Antonio Rivero, MD, PhD||Hospital Universitario Reina Sofia. Cordoba|
|Principal Investigator:||Mª Jose Rios-Villegas, MD, PhD||Hospital Universitario Viren MAcarena. Sevilla|
|Principal Investigator:||Juan A. Pineda, MD, PhD||Hospital Universitario de Valme. Sevilla|
|Responsible Party:||Antonio Rivero, Luis Fernando Lopez-Cortes, Sociedad Andaluza de Enfermedades Infecciosas|
|ClinicalTrials.gov Identifier:||NCT01006031 History of Changes|
|Other Study ID Numbers:||HEPAVIR_IFN_2009|
|Study First Received:||October 29, 2009|
|Last Updated:||December 28, 2011|
Keywords provided by Antonio Rivero, Sociedad Andaluza de Enfermedades Infecciosas:Liver cirrhosis
Hepatitis C virus
Pegylated interferon alfa-2a
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on May 24, 2020
This information is provided by ClinicalTrials.gov.