Phase IV Study to Evaluate the Efficacy/Safety to Extend Treatment and High Dose of Ribavirin in co-Infected Patients
NCT ID: NCT00526448
Last Updated: 2009-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
384 participants
INTERVENTIONAL
2007-06-30
2010-02-28
Brief Summary
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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).
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Peginterferon alfa-2a 180 mcg/week + ribavirin 2000 mg/day + epoetin beta 450 UI/week
ribavirin
2000 mg/day
Peginterferon alfa-2a
Peginterferon alfa-2a 180 mcg/week
epoetin beta
epoetin beta 450 UI/week
2
Peginterferon alfa-2a 180 mcg/week + ribavirin 1000-1200 mg/day
ribavirin
1000-1200 mg/day
Peginterferon alfa-2a
Peginterferon alfa-2a 180 mcg/week
Interventions
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ribavirin
2000 mg/day
ribavirin
1000-1200 mg/day
Peginterferon alfa-2a
Peginterferon alfa-2a 180 mcg/week
epoetin beta
epoetin beta 450 UI/week
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Hospital Carlos III, Madrid
OTHER
Principal Investigators
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Vicente Soriano, Dr
Role: STUDY_CHAIR
Hospital Carlos III. Madrid. Spain
Locations
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Hospital Juan Canalejo
A Coruña, A Coruña, Spain
Hospital Txagorritxu
Vitoria-Gasteiz, Alava, Spain
Hospital de Albacete
Albacete, Albacete, Spain
Hospital General de Elche
Elche, Alicante, Spain
Hospital Son Dureta
Palma de Mallorca, Balearic Islands, Spain
Hospital Santa Creu y Sant Pau
Barcelona, Barcelona, Spain
Hospital Parc Taulí
Sabadell, Barcelona, Spain
Hospital General de Jerez de la Frontera
Jerez de la Frontera, Cadiz, Spain
Hospital Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital General de Fuerteventura
Puerto del Rosario, Fuerteventura, Spain
Hospital Doctor Negrín
Las Palmas de Gran Canarias, Gran Canaria, Spain
Hospital Clínico san Cecilio
Granada, Granada, Spain
Hospital San Jorge
Huesca, Huesca, Spain
Hospital Arquitecto Marcide
Ferrol, La Coruña, Spain
Hospital Clínico Universitario
Santiago, La Coruña, Spain
Hospital Xeral-Caldé
Lugo, Lugo, Spain
Hospital de Alcorcon
Alcorcón, Madrid, Spain
Hospital Severo Ochoa
Leganés, Madrid, Spain
Hospital de la Princesa
Madrid, Madrid, Spain
Hospital Gregorio Marañón
Madrid, Madrid, Spain
Hospital Carlos III
Madrid, Madrid, Spain
Hospital Clínico San Carlos
Madrid, Madrid, Spain
Hospital 12 de Octubre
Madrid, Madrid, Spain
Hospital Santa Maria del Rosell
Murcia, Murcia, Spain
Hospital Clínico Virgen de la Victoria
Málaga, Málaga, Spain
Hospital Xeral-Cíes
Vigo, Pontevedra, Spain
Hospital do Meixoeiro
Vigo, Pontevedra, Spain
Hospital Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital Clínico de Salamanca
Salamanca, Salamanca, Spain
Hospital General de la Palma
La Palma, Santa Cruz de Tenerife, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain
Hospital de la Candelaria
Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain
Hospital Virgen de la Macarena
Seville, Sevilla, Spain
Hospital de Valme
Seville, Sevilla, Spain
Hospital Universitario la Fé
Valencia, Valencia, Spain
Hospial Clinico Universitario de Valencia
Valencia, Valencia, Spain
Hospital Clínico de Valladolid
Valladolid, Valladolid, Spain
Hospital de Cruces
Barakaldo, Vizcaya, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Zaragoza, Spain
Hospital Miguel Servet
Zaragoza, Zaragoza, Spain
Countries
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Central Contacts
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Facility Contacts
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Jose Adolfo Garcia Henarejos, Dr.
Role: primary
References
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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.
Other Identifiers
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2006-005940-99
Identifier Type: -
Identifier Source: org_study_id
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