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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Hospital Carlos III, Madrid.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital Carlos III, Madrid
ClinicalTrials.gov Identifier:
NCT00526448
First received: September 5, 2007
Last updated: January 28, 2009
Last verified: January 2009
  Purpose

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).


Condition Intervention Phase
Chronic Hepatitis C
Drug: ribavirin
Drug: Peginterferon alfa-2a
Drug: epoetin beta
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hospital Carlos III, Madrid:

Primary Outcome Measures:
  • % patients with RNA-HCV < 50 UI/ml [ Time Frame: 24 weeks after the end of treatment ]

Secondary Outcome Measures:
  • % patients with RNA-HCV < 50 UI/ml [ Time Frame: 4 weeks on treatment ]

Estimated Enrollment: 384
Study Start Date: June 2007
Estimated Study Completion Date: February 2010
Arms Assigned Interventions
Experimental: 1
Peginterferon alfa-2a 180 mcg/week + ribavirin 2000 mg/day + epoetin beta 450 UI/week
Drug: ribavirin
2000 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
1000-1200 mg/day
Drug: Peginterferon alfa-2a
Peginterferon alfa-2a 180 mcg/week

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).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing 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: NCT00526448

Contacts
Contact: Vicente Soriano, Dr +34914532500 vsoriano@dragonet.es
Contact: Pablo Barreiro, Dr +34914532500 pbarreiro@v4066.drago.net

Locations
Spain
Hospital Txagorritxu Not yet recruiting
Vitoria, Alava, Spain, 01009
Contact: Joseba Portu, Dr.    +3494 5007000 ext 5326    jportu@htxa.osakidetza.net   
Principal Investigator: Joseba Portu, Dr.         
Sub-Investigator: Miguel Aldamiz, Dr         
Hospital General de Elche Not yet recruiting
Elche, Alicante, Spain, 03203
Contact: Clara Maria Escolano, Dr.    +34966 679 154    cescolanoh@coma.es   
Principal Investigator: Clara Maria Escolano, Dr.         
Hospital Central de Asturias Not yet recruiting
Oviedo, Asturias, Spain, 33006
Contact: Victor Asensi, Dr.    +34985108000    vasensia@medynet.com   
Principal Investigator: Victor Asensi, Dr.         
Hospital Son Dureta Not yet recruiting
Palma de Mallorca, Baleares, Spain, 07014
Contact: Lucia Bonet, Dr.    +34971175000    lbonet@hsd.es   
Principal Investigator: Lucia Bonet, Dr.         
Sub-Investigator: Ana Escarda, Dr         
Sub-Investigator: Pere Vaquer, Dr         
Hospital Parc Taulí Not yet recruiting
Sabadell, Barcelona, Spain, 08208
Contact: Manuel Cervantes, Dr.    +34937231010    mcervantes@cspt.es   
Principal Investigator: Manuel Cervantes, Dr.         
Hospital General de Jerez de la Frontera Not yet recruiting
Jerez de la Frontera, Cadiz, Spain, 11407
Contact: Alberto Terrón    +34 956 032 062    jaterron@hotmail.com   
Principal Investigator: Alberto Terrón, Dr.         
Sub-Investigator: Ana Ruiz, Dr         
Hospital Marqués de Valdecilla Not yet recruiting
Santander, Cantabria, Spain, 39008
Contact: Santiago Echevarria, Dr.    +34942202669    mirevs@humv.es   
Contact: Carmen Fariña, Dr.    +34942203375    mirfac@humv.es   
Principal Investigator: Santiago Echevarria, Dr.         
Principal Investigator: Carmen Fariña, Dr.         
Hospital General de Fuerteventura Not yet recruiting
Puerto del Rosario, Fuerteventura, Spain, 35600
Contact: Jesús Flores, Dr.       jfmagad@terra.es   
Principal Investigator: Jesús Flores, Dr.         
Hospital Doctor Negrín Not yet recruiting
Las Palmas de Gran Canarias, Gran Canaria, Spain, 35020
Contact: Rafael Granados, Dr.    +34928 450 683    rafagramon@wanadoo.es   
Contact: Miguel Angel Cardenas, Dr.       mcarsa2@hotmail.com   
Principal Investigator: Rafael Granados, Dr.         
Sub-Investigator: Miguel Ángel Cárdenas, Dr.         
Hospital Arquitecto Marcide Not yet recruiting
Ferrol, La Coruña, Spain, 15405
Contact: Ana Mariño, Dr    +34981334000    ana.marino.callejo@sergas.es   
Principal Investigator: Ana Mariño, Dr         
Hospital Clínico Universitario Not yet recruiting
Santiago, La Coruña, Spain, 15706
Contact: Elena Losada, Dr    +34981195266    elena.losada.arias@sergas.es   
Contact: Arturo Prieto, Dr    +34981195266    arturo.prieto.martinez@sergas.es   
Principal Investigator: Elena Losada, Dr         
Hospital de Alcorcon Not yet recruiting
Alcorcon, Madrid, Spain, 28922
Contact: Juan Emilio Losa, Dr.    +3491 6219400    jelosa@fhalcorcon.es   
Principal Investigator: Juan Emilio Losa, Dr.         
Sub-Investigator: María Velasco, Dr         
Sub-Investigator: Leonor Moreno, Dr         
Hospital Severo Ochoa Not yet recruiting
Leganés, Madrid, Spain, 28911
Contact: Rafael Rodriguez-Rosado, Dr.       rafael.rrosado@gmail.com   
Principal Investigator: Rafael Rodriguez-Rosado, Dr.         
Hospital do Meixoeiro Not yet recruiting
Vigo, Pontevedra, Spain, 36214
Contact: Luis Morano, Dr.    +34986 81 11 11 ext 11386    luis.morano.amado@sergas.es   
Principal Investigator: Luis Morano, Dr.         
Hospital Xeral-Cíes Recruiting
Vigo, Pontevedra, Spain, 36204
Contact: Celia Miralles, Dr    +34986816000 ext 16104    maria.celia.miralles.alvarez@sergas.es   
Contact: Antonio Ocampo, Dr    +34986816000 ext 16104    aocampo@arrakis.es   
Principal Investigator: Celia Miralles, Dr         
Principal Investigator: Antonio Ocampo, Dr         
Hospital Universitario de Canarias Not yet recruiting
La Laguna, Santa Cruz de Tenerife, Spain, 38320
Contact: Remedios Alemán, Dr.    +34922678000    mraleman@comtf.es   
Contact: Juan Luis Gómez, Dr.    +34922678000    infecciones@huc.canarias.org   
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.         
Hospital General de la Palma Not yet recruiting
La Palma, Santa Cruz de Tenerife, Spain, 38713
Contact: Vicente Pueyo, Dr.    +34922185372    vpueyo@hotmail.com   
Principal Investigator: Vicente Pueyo, Dr.         
Hospital de Cruces Recruiting
Baracaldo, Vizcaya, Spain, 48913
Contact: Koldo Aguirrebengoa, Dr    +34946006379    kaguirrebengoa@hcru.osakidetza.net   
Principal Investigator: Koldo Aguirrebengoa, Dr         
Hospital Juan Canalejo Not yet recruiting
A Coruña, Spain, 15006
Contact: Angeles Castro, Dr.       miriamca@udc.es   
Contact: Jose Domingo Pedreira, Dr.       MInternaB@canalejo.org   
Principal Investigator: Angeles Castro, Dr.         
Sub-Investigator: Jose Domingo Pedreira, Dr.         
Sub-Investigator: Soledad López, Dr.         
Hospital de Albacete Not yet recruiting
Albacete, Spain, 02006
Contact: Elisa Martínez Alfaro, Dr.    +34967 597 253    emartineza@ono.es   
Principal Investigator: Elisa Martínez Alfaro, Dr.         
Hospital Santa Creu y Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Josep Cadafalch, Dr.    +3493 556 56 24    jcadafalch@hsp.santpau.es   
Contact: Josep Maria Guardiola, Dr.    +3493 556 56 24    jguardiola@hsp.santpau.es   
Principal Investigator: Josep Cadafalch, Dr.         
Sub-Investigator: Josep Maria Guardiola, Dr.         
Sub-Investigator: María A. Sambeat, Dr         
Sub-Investigator: Pere Domingo, Dr         
Hospital Clínico san Cecilio Not yet recruiting
Granada, Spain, 18012
Contact: Jose Hernandez Quero, Dr.    +34958 249 079    jhquero@ugr.es   
Principal Investigator: José Hernandez Quero, Dr.         
Sub-Investigator: Alejandro Pena, Dr         
Sub-Investigator: Jorge Parra, Dr         
Hospital San Jorge Not yet recruiting
Huesca, Spain, 22004
Contact: Miguel Angel Berdú, Dr    +34974247000    med001689@saludalia.com   
Principal Investigator: Miguel Angel Berdú, Dr         
Sub-Investigator: Miguel Egido, Dr         
Hospital Xeral-Caldé Not yet recruiting
Lugo, Spain, 27004
Contact: Juan Carlos Corredoira, Dr.    +34982 29 62 60    juan.corredoira.sanchez@sergas.es   
Contact: Maria José Lopez, Dr.    +34982 29 62 60    mariajose.lopez.alvarez@sergas.es   
Principal Investigator: Juan Carlos Corredoira, Dr.         
Sub-Investigator: Maria José Lopez, Dr.         
Hospital Clínico San Carlos Not yet recruiting
Madrid, Spain, 28040
Contact: Maria Jesús Téllez, Dr.    +3491 3303538    mjtellezm@hotmail.com   
Principal Investigator: Maria Jesús Téllez, Dr.         
Sub-Investigator: Vicente Estrada, Dr         
Sub-Investigator: Jorge Verga, Dr         
Sub-Investigator: Mónica Fuster, Dr         
Hospital Carlos III Recruiting
Madrid, Spain, 28029
Contact: Vicente Soriano, Dr    +34914532500    vsoriano@dragonet.es   
Contact: Pablo Barreiro, Dr    +34914532500    pbarreiro@v4066.drago.net   
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.         
Hospital 12 de Octubre Not yet recruiting
Madrid, Spain, 28041
Contact: Rafael Rubio, Dr.    +3491 390 80 28    rrubiog@saludalia.com   
Principal Investigator: Rafael Rubio, Dr.         
Hospital de la Princesa Not yet recruiting
Madrid, Spain, 28006
Contact: Ignacio Santos, Dr.    +3491 5202236    isantosg@hotmail.com   
Principal Investigator: Ignacio Santos, Dr.         
Sub-Investigator: Raquel Carrillo, Dr         
Hospital Gregorio Marañón Not yet recruiting
Madrid, Spain, 28007
Contact: Pilar Miralles, Dr.       pmiralles.hgugm@salud.madrid.org   
Principal Investigator: Pilar Miralles, Dr.         
Hospital Santa Maria del Rosell Not yet recruiting
Murcia, Spain, 30203
Contact: Jose Adolfo Garcia Henarejos, Dr.    +34968325226      
Principal Investigator: Jose Adolfo Garcia Henarejos, Dr.         
Hospital Clínico Virgen de la Victoria Recruiting
Málaga, Spain, 29010
Contact: Mercedes González, Dr.    +34952 649 393    med006801@saludalia.com   
Principal Investigator: Mercedes Gonzalez, Dr.         
Sub-Investigator: Josefa Ruiz, Dr         
Sub-Investigator: Jesús Santos, Dr         
Sub-Investigator: Manuel Márquez, Dr         
Hospital Clínico de Salamanca Not yet recruiting
Salamanca, Spain, 37007
Contact: Alicia Iglesias, Gómez    +34923291100    a_iglesias74@yahoo.es   
Contact: Miguel Cordero, Dr.    +34923291100    magnus@usal.es   
Principal Investigator: Alicia Iglesias, Dr.         
Sub-Investigator: Miguel Cordero, Dr.         
Hospital de la Candelaria Not yet recruiting
Santa Cruz de Tenerife, Spain, 38010
Contact: Marcelino Hayek, Dr.    +34922 60 20 21    ihayper@gobiernodecanarias.org   
Principal Investigator: Marcelino Hayek, Dr.         
Hospital de Valme Not yet recruiting
Sevilla, Spain, 41014
Contact: Juan Antonio Pineda, Dr.    +34955 015 887    japineda@telefonica.net   
Principal Investigator: Juan Antonio Pineda, Dr.         
Sub-Investigator: Fernando Lozano de León, Dr         
Sub-Investigator: Juan Macías, Dr         
Sub-Investigator: Eva Recio, Dr         
Hospital Virgen de la Macarena Not yet recruiting
Sevilla, Spain, 41009
Contact: Maria José Rios, Dr.    +34955 008 520    MJRIOSVILLEGAS@terra.es   
Principal Investigator: Maria José Rios, Dr.         
Sub-Investigator: Angel Domínguez, Dr         
Hospial Clinico Universitario de Valencia Not yet recruiting
Valencia, Spain, 46010
Contact: Maria José Galindo, Dr.    +34963862600    pepagal@hotmail.com   
Principal Investigator: Maria José Galindo, Dr.         
Sub-Investigator: José Gaix, Dr         
Hospital Universitario la Fé Not yet recruiting
Valencia, Spain, 46009
Contact: José La Cruz, Dr.    +3496 386 27 00 ext 40352    lacruz_jos@gva.es   
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         
Hospital Clínico de Valladolid Not yet recruiting
Valladolid, Spain, 47011
Contact: Miguel Angel del Pozo, Dr.    +34983420000 ext 343    "mdelpozo@med.uva.es mdelpozo@med.uva.es   
Contact: Isabel González Gilabert, Dr.    +34983420000 ext 343    isabel46@ono.com   
Principal Investigator: Miguel Angel del Pozo, Dr.         
Sub-Investigator: Isabel González Gilabert, Dr.         
Hospital Clínico Universitario Lozano Blesa Not yet recruiting
Zaragoza, Spain, 50009
Contact: Isabel Sanjoaquín, Dr.    +34976 556400 ext 2664    isanjoaquin@able.es   
Contact: Santiago Letona, Dr.       santiagoletona@yahoo.es   
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         
Hospital Miguel Servet Not yet recruiting
Zaragoza, Spain, 50009
Contact: Carlos Ramos, Dr.       cramosp@salud.aragon.es   
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         
Sponsors and Collaborators
Hospital Carlos III, Madrid
Investigators
Study Chair: Vicente Soriano, Dr Hospital Carlos III. Madrid. Spain
  More Information

No publications provided by Hospital Carlos III, Madrid

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00526448     History of Changes
Other Study ID Numbers: 2006-005940-99
Study First Received: September 5, 2007
Last Updated: January 28, 2009
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Carlos III, Madrid:
high dose of ribavirin
extend treatment duration
tailoring treatment

Additional relevant MeSH terms:
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Flaviviridae Infections
Hepatitis
Hepatitis, Viral, Human
Liver Diseases
RNA Virus Infections
Virus Diseases
Interferon-alpha
Peginterferon alfa-2a
Ribavirin
Anti-Infective Agents
Antimetabolites
Antiviral Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014