Phase IV Study to Evaluate the Efficacy/Safety to Extend Treatment and High Dose of Ribavirin in co-Infected Patients
PERICO
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
1 other identifier
interventional
384
1 country
40
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2007
Typical duration for phase_4
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 5, 2007
CompletedFirst Posted
Study publicly available on registry
September 10, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedJanuary 29, 2009
January 1, 2009
September 5, 2007
January 28, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
% patients with RNA-HCV < 50 UI/ml
24 weeks after the end of treatment
Secondary Outcomes (1)
% patients with RNA-HCV < 50 UI/ml
4 weeks on treatment
Study Arms (2)
1
EXPERIMENTALPeginterferon alfa-2a 180 mcg/week + ribavirin 2000 mg/day + epoetin beta 450 UI/week
2
ACTIVE COMPARATORPeginterferon alfa-2a 180 mcg/week + ribavirin 1000-1200 mg/day
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Hospital Juan Canalejo
A Coruña, A Coruña, 15006, Spain
Hospital Txagorritxu
Vitoria-Gasteiz, Alava, 01009, Spain
Hospital de Albacete
Albacete, Albacete, 02006, Spain
Hospital General de Elche
Elche, Alicante, 03203, Spain
Hospital Son Dureta
Palma de Mallorca, Balearic Islands, 07014, Spain
Hospital Santa Creu y Sant Pau
Barcelona, Barcelona, 08025, Spain
Hospital Parc Taulí
Sabadell, Barcelona, 08208, Spain
Hospital General de Jerez de la Frontera
Jerez de la Frontera, Cadiz, 11407, Spain
Hospital Marqués de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital General de Fuerteventura
Puerto del Rosario, Fuerteventura, 35600, Spain
Hospital Doctor Negrín
Las Palmas de Gran Canarias, Gran Canaria, 35020, Spain
Hospital Clínico san Cecilio
Granada, Granada, 18012, Spain
Hospital San Jorge
Huesca, Huesca, 22004, Spain
Hospital Arquitecto Marcide
Ferrol, La Coruña, 15405, Spain
Hospital Clínico Universitario
Santiago, La Coruña, 15706, Spain
Hospital Xeral-Caldé
Lugo, Lugo, 27004, Spain
Hospital de Alcorcon
Alcorcón, Madrid, 28922, Spain
Hospital Severo Ochoa
Leganés, Madrid, 28911, Spain
Hospital de la Princesa
Madrid, Madrid, 28006, Spain
Hospital Gregorio Marañón
Madrid, Madrid, 28007, Spain
Hospital Carlos III
Madrid, Madrid, 28029, Spain
Hospital Clínico San Carlos
Madrid, Madrid, 28040, Spain
Hospital 12 de Octubre
Madrid, Madrid, 28041, Spain
Hospital Santa Maria del Rosell
Murcia, Murcia, 30203, Spain
Hospital Clínico Virgen de la Victoria
Málaga, Málaga, 29010, Spain
Hospital Xeral-Cíes
Vigo, Pontevedra, 36204, Spain
Hospital do Meixoeiro
Vigo, Pontevedra, 36214, Spain
Hospital Central de Asturias
Oviedo, Principality of Asturias, 33006, Spain
Hospital Clínico de Salamanca
Salamanca, Salamanca, 37007, Spain
Hospital General de la Palma
La Palma, Santa Cruz de Tenerife, 38713, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38320, Spain
Hospital de la Candelaria
Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38010, Spain
Hospital Virgen de la Macarena
Seville, Sevilla, 41009, Spain
Hospital de Valme
Seville, Sevilla, 41014, Spain
Hospital Universitario la Fé
Valencia, Valencia, 46009, Spain
Hospial Clinico Universitario de Valencia
Valencia, Valencia, 46010, Spain
Hospital Clínico de Valladolid
Valladolid, Valladolid, 47011, Spain
Hospital de Cruces
Barakaldo, Vizcaya, 48913, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Zaragoza, 50009, Spain
Hospital Miguel Servet
Zaragoza, Zaragoza, 50009, Spain
Related Publications (1)
Vispo E, Labarga P, Guardiola JM, Barreiro P, Miralles C, Rubio R, Miralles P, Aguirrebengoa K, Portu J, Morello J, Rodriguez-Novoa S, Soriano V; PERICO Study Group. Preemptive erythropoietin plus high ribavirin doses to increase rapid virological responses in HIV patients treated for chronic hepatitis C. AIDS Res Hum Retroviruses. 2010 Apr;26(4):419-24. doi: 10.1089/aid.2009.0120.
PMID: 20377423DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Vicente Soriano, Dr
Hospital Carlos III. Madrid. Spain
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 5, 2007
First Posted
September 10, 2007
Study Start
June 1, 2007
Study Completion
February 1, 2010
Last Updated
January 29, 2009
Record last verified: 2009-01