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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. The completion date has passed and the status has not been verified in more than two years.
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   (Adult, Senior)
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

Locations
Spain
Hospital Txagorritxu
Vitoria, Alava, Spain, 01009
Hospital General de Elche
Elche, Alicante, Spain, 03203
Hospital Central de Asturias
Oviedo, Asturias, Spain, 33006
Hospital Son Dureta
Palma de Mallorca, Baleares, Spain, 07014
Hospital Parc Taulí
Sabadell, Barcelona, Spain, 08208
Hospital General de Jerez de la Frontera
Jerez de la Frontera, Cadiz, Spain, 11407
Hospital Marqués de Valdecilla
Santander, Cantabria, Spain, 39008
Hospital General de Fuerteventura
Puerto del Rosario, Fuerteventura, Spain, 35600
Hospital Doctor Negrín
Las Palmas de Gran Canarias, Gran Canaria, Spain, 35020
Hospital Arquitecto Marcide
Ferrol, La Coruña, Spain, 15405
Hospital Clínico Universitario
Santiago, La Coruña, Spain, 15706
Hospital de Alcorcon
Alcorcon, Madrid, Spain, 28922
Hospital Severo Ochoa
Leganés, Madrid, Spain, 28911
Hospital Xeral-Cíes
Vigo, Pontevedra, Spain, 36204
Hospital do Meixoeiro
Vigo, Pontevedra, Spain, 36214
Hospital Universitario de Canarias
La Laguna, Santa Cruz de Tenerife, Spain, 38320
Hospital General de la Palma
La Palma, Santa Cruz de Tenerife, Spain, 38713
Hospital de Cruces
Baracaldo, Vizcaya, Spain, 48913
Hospital Juan Canalejo
A Coruña, Spain, 15006
Hospital de Albacete
Albacete, Spain, 02006
Hospital Santa Creu y Sant Pau
Barcelona, Spain, 08025
Hospital Clínico san Cecilio
Granada, Spain, 18012
Hospital San Jorge
Huesca, Spain, 22004
Hospital Xeral-Caldé
Lugo, Spain, 27004
Hospital de la Princesa
Madrid, Spain, 28006
Hospital Gregorio Marañón
Madrid, Spain, 28007
Hospital Carlos III
Madrid, Spain, 28029
Hospital Clínico San Carlos
Madrid, Spain, 28040
Hospital 12 de Octubre
Madrid, Spain, 28041
Hospital Santa Maria del Rosell
Murcia, Spain, 30203
Hospital Clínico Virgen de la Victoria
Málaga, Spain, 29010
Hospital Clínico de Salamanca
Salamanca, Spain, 37007
Hospital de la Candelaria
Santa Cruz de Tenerife, Spain, 38010
Hospital Virgen de la Macarena
Sevilla, Spain, 41009
Hospital de Valme
Sevilla, Spain, 41014
Hospital Universitario la Fé
Valencia, Spain, 46009
Hospial Clinico Universitario de Valencia
Valencia, Spain, 46010
Hospital Clínico de Valladolid
Valladolid, Spain, 47011
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain, 50009
Hospital Miguel Servet
Zaragoza, Spain, 50009
Sponsors and Collaborators
Hospital Carlos III, Madrid
Investigators
Study Chair: Vicente Soriano, Dr Hospital Carlos III. Madrid. Spain
  More Information

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, 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
Immunologic Factors
Physiological Effects of Drugs
Hematinics

ClinicalTrials.gov processed this record on December 05, 2016