Phase IV Study to Evaluate the Efficacy/Safety to Extend Treatment and High Dose of Ribavirin in co-Infected Patients (PERICO)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00526448 |
Recruitment Status
: Unknown
Verified January 2009 by Hospital Carlos III, Madrid.
Recruitment status was: Recruiting
First Posted
: September 10, 2007
Last Update Posted
: January 29, 2009
|
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Hepatitis C | Drug: ribavirin Drug: Peginterferon alfa-2a Drug: epoetin beta | Phase 4 |
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 (Clinical Trial) |
Estimated Enrollment : | 384 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | June 2007 |
Estimated Study Completion Date : | February 2010 |

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: 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
|
- % patients with RNA-HCV < 50 UI/ml [ Time Frame: 24 weeks after the end of treatment ]
- % patients with RNA-HCV < 50 UI/ml [ Time Frame: 4 weeks on treatment ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00526448
Contact: Vicente Soriano, Dr | +34914532500 | vsoriano@dragonet.es | |
Contact: Pablo Barreiro, Dr | +34914532500 | pbarreiro@v4066.drago.net |
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 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 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 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 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 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 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 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 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 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 | |
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 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 | |
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 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 |
Study Chair: | Vicente Soriano, Dr | Hospital Carlos III. Madrid. Spain |
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 |
First Posted: | September 10, 2007 Key Record Dates |
Last Update Posted: | January 29, 2009 |
Last Verified: | January 2009 |
Keywords provided by Hospital Carlos III, Madrid:
high dose of ribavirin extend treatment duration tailoring treatment |
Additional relevant MeSH terms:
Hepatitis C Hepatitis, Chronic Hepatitis C, Chronic Hepatitis, Viral, Human Virus Diseases Flaviviridae Infections RNA Virus Infections Hepatitis Liver Diseases Digestive System Diseases Ribavirin |
Peginterferon alfa-2a Interferon-alpha Epoetin Alfa Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Hematinics Immunologic Factors Physiological Effects of Drugs |