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Retreatment With High Doses of pegIFN Alfa-2a and Ribavirin of Previous Nonresponders HIV-coinfected Patients With Cirrhosis Due to HCV 1-4

Information source: Sociedad Andaluza de Enfermedades Infecciosas
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Liver Cirrhosis; Hepatitis C Virus; HIV Infection

Intervention: Pegylated interferon alfa-2a and Ribavirin (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Sociedad Andaluza de Enfermedades Infecciosas

Official(s) and/or principal investigator(s):
Luis F Lopez-Cortes, MD, PhD, Study Director, Affiliation: Instituto de Biomedicina de Sevilla. Hospitales Universitarios Virgen del Rocío
Luis F Lopez-Cortes, MD, PhD, Principal Investigator, Affiliation: Instituto de Biomedicina de Sevilla. Hospitales Universitarios Virgen del Rocio
Antonio Rivero, MD, PhD, Principal Investigator, Affiliation: Hospital Universitario Reina Sofia. Cordoba
Mª Jose Rios-Villegas, MD, PhD, Principal Investigator, Affiliation: Hospital Universitario Viren MAcarena. Sevilla
Juan A. Pineda, MD, PhD, Principal Investigator, Affiliation: Hospital Universitario de Valme. Sevilla

Summary

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.

Clinical Details

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.

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Sustained viral response (undetectable serum HCV-RNA)

Secondary outcome:

Relationships between the plasma interferon an ribavirin concentrations and efficacy

safety and tolerability of the studied medications

The evolution of liver fibrosis will be evaluated comparing the basal and end of treatment results of transient elastometry

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Locations and Contacts

Hospital Universitario Reina Sofía, Cordoba, Spain

Hospitales Universitarios Virgen del Rocío, Seviila, Spain

Hospital Universitario de Valme, Sevilla, Spain

Hospital Universitario Virgen Macarena, Sevilla, Spain

Additional Information

Starting date: October 2009
Last updated: December 28, 2011

Page last updated: August 23, 2015

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