Phase IV Study to Evaluate the Efficacy/Safety to Extend Treatment and High Dose of Ribavirin in co-Infected Patients (PERICO)

January 28, 2009 updated by: Hospital Carlos III, Madrid

Open, Multicentre,Randomized Phase IV Trial to Evaluate Efficacy/Safety to Extend Treatment Duration With Peginterferon Alfa-2a+High Dose of Ribavirin Supporting Epo β in Treatment of CHC in HIV-HCV Patients Who Not Clear Virus at Week 4

To compare the sustained virological response (SVR = ribonucleic acid (RNA) - hepatitis C virus (HCV) undetectable at week 24 before end the treatment) in chronic hepatitis C patients genotype 1-4 co-infected with HIV-HCV, treated with Peginterferón alfa-2a (40 KD) 180 µg/week and Ribavirin (2000 mg/day during 4 weeks, follow of 1000-1200 mg/day, according to body weight); versus Peginterferón alfa-2a (40 KD) 180 μg/week and Ribavirin (1000-1200 mg/day, according to body weight).

To evaluate the impact to extend the treatment with Peginterferon alfa-2a and Ribavirin to week 72, in SVR of these patients with genotypes 1-4 without rapid virological response (RVR = RNA - HCV undetectable at 4 week).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The PRESCO study (ribavirin dose 1000-1200 mg/day) emphasized that optimal ribavirin exposure seems to be crucial to maximize sustained virological response and minimize the incidence of relapses after treatment discontinuations.

Recent reports showed that it is beneficial to extend the treatment duration in patients without rapid virological response at 4 weeks (RNA-HCV < 50 UI/ml).

Study Type

Interventional

Enrollment (Anticipated)

384

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • A Coruña, Spain, 15006
        • Not yet recruiting
        • Hospital Juan Canalejo
        • Contact:
        • Contact:
        • Principal Investigator:
          • Angeles Castro, Dr.
        • Sub-Investigator:
          • Jose Domingo Pedreira, Dr.
        • Sub-Investigator:
          • Soledad López, Dr.
      • Albacete, Spain, 02006
        • Not yet recruiting
        • Hospital de Albacete
        • Contact:
        • Principal Investigator:
          • Elisa Martínez Alfaro, Dr.
      • Barcelona, Spain, 08025
        • Recruiting
        • Hospital Santa Creu Y Sant Pau
        • Contact:
        • Contact:
        • Principal Investigator:
          • Josep Cadafalch, Dr.
        • Sub-Investigator:
          • Josep Maria Guardiola, Dr.
        • Sub-Investigator:
          • María A. Sambeat, Dr
        • Sub-Investigator:
          • Pere Domingo, Dr
      • Granada, Spain, 18012
        • Not yet recruiting
        • Hospital Clínico San Cecilio
        • Contact:
          • Jose Hernandez Quero, Dr.
          • Phone Number: +34958 249 079
          • Email: jhquero@ugr.es
        • Principal Investigator:
          • José Hernandez Quero, Dr.
        • Sub-Investigator:
          • Alejandro Pena, Dr
        • Sub-Investigator:
          • Jorge Parra, Dr
      • Huesca, Spain, 22004
        • Not yet recruiting
        • Hospital San Jorge
        • Contact:
        • Principal Investigator:
          • Miguel Angel Berdú, Dr
        • Sub-Investigator:
          • Miguel Egido, Dr
      • Lugo, Spain, 27004
        • Not yet recruiting
        • Hospital Xeral-Caldé
        • Contact:
        • Contact:
        • Principal Investigator:
          • Juan Carlos Corredoira, Dr.
        • Sub-Investigator:
          • Maria José Lopez, Dr.
      • Madrid, Spain, 28006
        • Not yet recruiting
        • Hospital de La Princesa
        • Contact:
        • Principal Investigator:
          • Ignacio Santos, Dr.
        • Sub-Investigator:
          • Raquel Carrillo, Dr
      • Madrid, Spain, 28040
        • Not yet recruiting
        • Hospital Clinico San Carlos
        • Contact:
        • Principal Investigator:
          • Maria Jesús Téllez, Dr.
        • Sub-Investigator:
          • Vicente Estrada, Dr
        • Sub-Investigator:
          • Jorge Verga, Dr
        • Sub-Investigator:
          • Mónica Fuster, Dr
      • Madrid, Spain, 28007
        • Not yet recruiting
        • Hospital Gregorio Marañon
        • Contact:
        • Principal Investigator:
          • Pilar Miralles, Dr.
      • Madrid, Spain, 28029
        • Recruiting
        • Hospital Carlos III
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vicente Soriano, Dr
        • Sub-Investigator:
          • Pablo Barreiro, Dr
        • Sub-Investigator:
          • Pablo Labarga, Dr
        • Sub-Investigator:
          • Luz Martin-Carbonero, Dr
        • Sub-Investigator:
          • Javier García-Samaniego, Dr
        • Sub-Investigator:
          • José Martínez Alarcón, Dr
        • Sub-Investigator:
          • Sonia Rodríguez Novoa, Dr
        • Sub-Investigator:
          • Eugenia Vispo, Dr.
      • Madrid, Spain, 28041
        • Not yet recruiting
        • Hospital 12 de Octubre
        • Contact:
        • Principal Investigator:
          • Rafael Rubio, Dr.
      • Murcia, Spain, 30203
        • Not yet recruiting
        • Hospital Santa Maria del Rosell
        • Contact:
          • Jose Adolfo Garcia Henarejos, Dr.
          • Phone Number: +34968325226
        • Principal Investigator:
          • Jose Adolfo Garcia Henarejos, Dr.
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Clínico Virgen de la Victoria
        • Contact:
        • Principal Investigator:
          • Mercedes Gonzalez, Dr.
        • Sub-Investigator:
          • Josefa Ruiz, Dr
        • Sub-Investigator:
          • Jesús Santos, Dr
        • Sub-Investigator:
          • Manuel Márquez, Dr
      • Salamanca, Spain, 37007
        • Not yet recruiting
        • Hospital Clínico de Salamanca
        • Contact:
        • Contact:
          • Miguel Cordero, Dr.
          • Phone Number: +34923291100
          • Email: magnus@usal.es
        • Principal Investigator:
          • Alicia Iglesias, Dr.
        • Sub-Investigator:
          • Miguel Cordero, Dr.
      • Santa Cruz de Tenerife, Spain, 38010
        • Not yet recruiting
        • Hospital de la Candelaria
        • Contact:
        • Principal Investigator:
          • Marcelino Hayek, Dr.
      • Sevilla, Spain, 41009
        • Not yet recruiting
        • Hospital Virgen de la Macarena
        • Contact:
        • Principal Investigator:
          • Maria José Rios, Dr.
        • Sub-Investigator:
          • Angel Domínguez, Dr
      • Sevilla, Spain, 41014
        • Not yet recruiting
        • Hospital De Valme
        • Contact:
        • Principal Investigator:
          • Juan Antonio Pineda, Dr.
        • Sub-Investigator:
          • Fernando Lozano de León, Dr
        • Sub-Investigator:
          • Juan Macías, Dr
        • Sub-Investigator:
          • Eva Recio, Dr
      • Valencia, Spain, 46009
        • Not yet recruiting
        • Hospital Universitario la Fe
        • Contact:
        • Principal Investigator:
          • José La Cruz, Dr.
        • Sub-Investigator:
          • José López-Aldeguer, Dr
        • Sub-Investigator:
          • Marino Blanes, Dr
        • Sub-Investigator:
          • Miguel Salvert, Dr
        • Sub-Investigator:
          • Eva Calabuig, Dr
        • Sub-Investigator:
          • Marta Montero, Dr
        • Sub-Investigator:
          • Sandra Cuellar, Dr
      • Valencia, Spain, 46010
        • Not yet recruiting
        • Hospial Clinico Universitario de Valencia
        • Contact:
        • Principal Investigator:
          • Maria José Galindo, Dr.
        • Sub-Investigator:
          • José Gaix, Dr
      • Valladolid, Spain, 47011
        • Not yet recruiting
        • Hospital Clínico de Valladolid
        • Contact:
        • Contact:
          • Isabel González Gilabert, Dr.
          • Phone Number: 343 +34983420000
          • Email: isabel46@ono.com
        • Principal Investigator:
          • Miguel Angel del Pozo, Dr.
        • Sub-Investigator:
          • Isabel González Gilabert, Dr.
      • Zaragoza, Spain, 50009
        • Not yet recruiting
        • Hospital Clínico Universitario Lozano Blesa
        • Contact:
        • Contact:
        • Principal Investigator:
          • Isabel Sanjoaquín, Dr.
        • Principal Investigator:
          • Santiago Letona, Dr.
        • Sub-Investigator:
          • Juan Antonio Amiguet, Dr
        • Sub-Investigator:
          • Julián Cuesta, Dr
        • Sub-Investigator:
          • María José Crusells, Dr
      • Zaragoza, Spain, 50009
        • Not yet recruiting
        • Hospital Miguel Servet
        • Contact:
        • Principal Investigator:
          • Carlos Ramos, Dr.
        • Sub-Investigator:
          • Piedad Arazo, Dr.
        • Sub-Investigator:
          • Ascensión Pascual, Dr
        • Sub-Investigator:
          • Desiré Gil, Dr
        • Sub-Investigator:
          • José Miguel Aguirre, Dr
    • Alava
      • Vitoria, Alava, Spain, 01009
        • Not yet recruiting
        • Hospital Txagorritxu
        • Contact:
        • Principal Investigator:
          • Joseba Portu, Dr.
        • Sub-Investigator:
          • Miguel Aldamiz, Dr
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Not yet recruiting
        • Hospital General de Elche
        • Contact:
        • Principal Investigator:
          • Clara Maria Escolano, Dr.
    • Asturias
      • Oviedo, Asturias, Spain, 33006
        • Not yet recruiting
        • Hospital Central de Asturias
        • Contact:
        • Principal Investigator:
          • Victor Asensi, Dr.
    • Baleares
      • Palma de Mallorca, Baleares, Spain, 07014
        • Not yet recruiting
        • Hospital Son Dureta
        • Contact:
          • Lucia Bonet, Dr.
          • Phone Number: +34971175000
          • Email: lbonet@hsd.es
        • Principal Investigator:
          • Lucia Bonet, Dr.
        • Sub-Investigator:
          • Ana Escarda, Dr
        • Sub-Investigator:
          • Pere Vaquer, Dr
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Not yet recruiting
        • Hospital Parc Tauli
        • Contact:
        • Principal Investigator:
          • Manuel Cervantes, Dr.
    • Cadiz
      • Jerez de la Frontera, Cadiz, Spain, 11407
        • Not yet recruiting
        • Hospital general de Jerez de la Frontera
        • Contact:
        • Principal Investigator:
          • Alberto Terrón, Dr.
        • Sub-Investigator:
          • Ana Ruiz, Dr
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Not yet recruiting
        • Hospital Marqués de Valdecilla
        • Contact:
          • Santiago Echevarria, Dr.
          • Phone Number: +34942202669
          • Email: mirevs@humv.es
        • Contact:
          • Carmen Fariña, Dr.
          • Phone Number: +34942203375
          • Email: mirfac@humv.es
        • Principal Investigator:
          • Santiago Echevarria, Dr.
        • Principal Investigator:
          • Carmen Fariña, Dr.
    • Fuerteventura
      • Puerto del Rosario, Fuerteventura, Spain, 35600
        • Not yet recruiting
        • Hospital General de Fuerteventura
        • Contact:
        • Principal Investigator:
          • Jesús Flores, Dr.
    • Gran Canaria
      • Las Palmas de Gran Canarias, Gran Canaria, Spain, 35020
        • Not yet recruiting
        • Hospital Doctor Negrín
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rafael Granados, Dr.
        • Sub-Investigator:
          • Miguel Ángel Cárdenas, Dr.
    • La Coruña
      • Ferrol, La Coruña, Spain, 15405
        • Not yet recruiting
        • Hospital Arquitecto Marcide
        • Contact:
        • Principal Investigator:
          • Ana Mariño, Dr
      • Santiago, La Coruña, Spain, 15706
    • Madrid
      • Alcorcon, Madrid, Spain, 28922
        • Not yet recruiting
        • Hospital de Alcorcón
        • Contact:
        • Principal Investigator:
          • Juan Emilio Losa, Dr.
        • Sub-Investigator:
          • María Velasco, Dr
        • Sub-Investigator:
          • Leonor Moreno, Dr
      • Leganés, Madrid, Spain, 28911
        • Not yet recruiting
        • Hospital Severo Ochoa
        • Contact:
        • Principal Investigator:
          • Rafael Rodriguez-Rosado, Dr.
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36204
        • Recruiting
        • Hospital Xeral-Cíes
        • Contact:
        • Contact:
        • Principal Investigator:
          • Celia Miralles, Dr
        • Principal Investigator:
          • Antonio Ocampo, Dr
      • Vigo, Pontevedra, Spain, 36214
        • Not yet recruiting
        • Hospital Do Meixoeiro
        • Contact:
        • Principal Investigator:
          • Luis Morano, Dr.
    • Santa Cruz de Tenerife
      • La Laguna, Santa Cruz de Tenerife, Spain, 38320
        • Not yet recruiting
        • Hospital Universitario de Canarias
        • Contact:
        • Contact:
        • Principal Investigator:
          • Remedios Alemán, Dr.
        • Sub-Investigator:
          • Juan Luis Gómez Sirvent, Dr.
        • Sub-Investigator:
          • Maria del Mar Alonso, Dr.
        • Sub-Investigator:
          • Ana López Lirola, Dr.
      • La Palma, Santa Cruz de Tenerife, Spain, 38713
        • Not yet recruiting
        • Hospital General de La Palma
        • Contact:
        • Principal Investigator:
          • Vicente Pueyo, Dr.
    • Vizcaya
      • Baracaldo, Vizcaya, Spain, 48913
        • Recruiting
        • Hospital de Cruces
        • Contact:
        • Principal Investigator:
          • Koldo Aguirrebengoa, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female patients > 18 years of age
  • Serologic evidence of anti-HCV
  • Detectable plasma HCV-RNA
  • Serologic evidence of HIV-1 infection
  • CD4 cell count >/= 250 cell/mm3
  • Stable status of HIV-1 infection in the opinion of the investigator
  • Patients on stable antiretroviral therapy (HAART) for at least 6 weeks prior to baseline whose HAART regimen (drugs and dosage) is expected to remain unaltered for the first 6 weeks of this study
  • Patients who have not been on HAART for at least 6 weeks prior to randomization who are willing to delay initiation of HAART therapy for at least 6 weeks
  • Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug
  • Willingness to give written informed consent

Exclusion Criteria:

  • Women with ongoing pregnancy or breast feeding
  • Male partners of women who are pregnant
  • IFN/ribavirin therapy at any previous time
  • Child Pugh > 6 (Child Pugh B or C)
  • History or conditions consistent with decompensated liver disease
  • Any investigational drug 6 weeks prior to the first dose of study drug (expanded access programs for HIV treatment are allowed)
  • Patients treated with didanosine and/or zidovudine
  • Positive test at anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, HBeAg
  • History or other evidence of a medical condition associated with chronic liver disease other than HCV
  • Hepatocarcinoma observed in the liver ecography
  • Serum concentrations of ceruloplasmin or alfa1-antitrypsin at screening consistent with an increased risk of metabolic liver disease
  • Active HIV-related opportunistic infection and/or malignancy requiring acute systemic therapy
  • Absolute neutrophil count (ANC) < 1500 cells/mm3
  • Hgb < 11 g/dL in women or 12 g/dL in men or any patient for whom anemia would be medically problematic
  • Hemoglobinopathy or any other cause of or tendency for hemolysis
  • Platelet count < 50,000 cells/mm3
  • History of G-CSF, GM-CSF or epo treatment during 3 months prior to the first dose of study drug
  • Serum creatinine level > 1.5 times the upper limit of normal at screening
  • History of severe psychiatric disease, especially depression
  • History of a severe seizure disorder or current anticonvulsant use
  • History of immunologically mediated disease
  • History or other evidence of chronic pulmonary disease associated with functional limitation
  • History of significant cardiac disease that could be worsened by acute anemia
  • History of thyroid disease poorly controlled on prescribed medications
  • Evidence of severe retinopathy
  • History of major organ transplantation with an existing functional graft
  • History or other evidence of severe illness, malignancy or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
  • History of any systemic anti-neoplastic or immunomodulatory treatment 6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study
  • Concomitant medication with rifampin/rifampicin, rifabutin, pyrazinamide, isoniazid, gancyclovir, thalidomide, oxymetholone, immunomodulatory treatments and systemic antiviral agents as adjuvant therapy for CHC
  • Drug use within 6 months of 1st dose and excessive alcohol consumption

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Peginterferon alfa-2a 180 mcg/week + ribavirin 2000 mg/day + epoetin beta 450 UI/week
Drug: ribavirin
2000 mg/day
Drug: ribavirin
1000-1200 mg/day
Drug: Peginterferon alfa-2a
Peginterferon alfa-2a 180 mcg/week
Drug: epoetin beta
epoetin beta 450 UI/week
Active Comparator: 2
Peginterferon alfa-2a 180 mcg/week + ribavirin 1000-1200 mg/day
Drug: ribavirin
2000 mg/day
Drug: ribavirin
1000-1200 mg/day
Drug: Peginterferon alfa-2a
Peginterferon alfa-2a 180 mcg/week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
% patients with RNA-HCV < 50 UI/ml
Time Frame: 24 weeks after the end of treatment
24 weeks after the end of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
% patients with RNA-HCV < 50 UI/ml
Time Frame: 4 weeks on treatment
4 weeks on treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Carlos III, Madrid

Investigators

  • Study Chair: Vicente Soriano, Dr, Hospital Carlos III. Madrid. Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Study Completion (Anticipated)

February 1, 2010

Study Registration Dates

First Submitted

September 5, 2007

First Submitted That Met QC Criteria

September 7, 2007

First Posted (Estimate)

September 10, 2007

Study Record Updates

Last Update Posted (Estimate)

January 29, 2009

Last Update Submitted That Met QC Criteria

January 28, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-005940-99

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Hepatitis C

Clinical Trials on ribavirin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe