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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.
Sponsor study identifier
interventional
25
1 country
4
Study Start
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2011
Actual (reported)Study Completion
December 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
October 29, 2009
Actual (reported)November 2, 2009
Actual (reported)December 2011
Actual (reported)December 2011
Actual (reported)Sustained viral response (undetectable serum HCV-RNA)
Throughout treatment and 24 weeks after finishing it
Relationships between the plasma interferon an ribavirin concentrations and efficacy
Throughout treatment and 24 weeks after finishing it.
safety and tolerability of the studied medications
Throughout treatment and 24 weeks after finishing it
HIV-coinfected patients with compensated cirrhosis by hepatitis C virus, genotype 1 or 4.
Pegylated interferon alfa-2a (360 ug per week) plus oral Ribavirin (800 mg b.i.d.) for 48 or 72 weeks. The treatment will be discontinued for patients who did not achieve a reduction with respect to baseline of at least 0.5 log10 IU/ml in plasma RNA-HCV levels at week 4 or 2 log10 UI/ml at week 12 and will be considered as viral failures. Duration: 48 weeks for patients reaching an undetectable plasma RNA\_HCV at week12 and 72 weeks for those without a negative viremia at week 12 but a reduction of at least 2 log10 IU/ml in RNA-HCV levels.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Pegylated interferon alfa-2a and Ribavirin
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordHospital Universitario Reina Sofía
Córdoba, Spain
Hospitales Universitarios Virgen del Rocío
Seviila, Spain
Hospital Universitario de Valme
Seville, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Luis F Lopez-Cortes, MD, PhD
Instituto de Biomedicina de Sevilla. Hospitales Universitarios Virgen del Rocío
Luis F Lopez-Cortes, MD, PhD
Instituto de Biomedicina de Sevilla. Hospitales Universitarios Virgen del Rocio
Antonio Rivero, MD, PhD
Hospital Universitario Reina Sofia. Cordoba
Mª Jose Rios-Villegas, MD, PhD
Hospital Universitario Viren MAcarena. Sevilla
25 participants (actual enrollment reported by the registry).
First Submitted
October 29, 2009
First Posted
November 2, 2009
Study Start
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
The evolution of liver fibrosis will be evaluated comparing the basal and end of treatment results of transient elastometry
baseline and after finishing treatment
Contact the study team to confirm eligibility.
Juan A. Pineda, MD, PhD
Hospital Universitario de Valme. Sevilla
Primary Completion
December 2011
Actual (reported)Study Completion
December 2011
Actual (reported)Last Updated
December 30, 2011
Record last verified: 2011-12
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Source: ClinicalTrials.gov.
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