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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

September 5, 2007
January 28, 2009
June 2007
Not Provided
% patients with RNA-HCV < 50 UI/ml [ Time Frame: 24 weeks after the end of treatment ]
Same as current
Complete list of historical versions of study NCT00526448 on ClinicalTrials.gov Archive Site
% patients with RNA-HCV < 50 UI/ml [ Time Frame: 4 weeks on treatment ]
% patients with RNA-HCV < 50 UI/ml [ Time Frame: 4 week on treatment ]
Not Provided
Not Provided
 
Phase IV Study to Evaluate the Efficacy/Safety to Extend Treatment and High Dose of Ribavirin in co-Infected Patients
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

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).

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).

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis C
  • Drug: ribavirin
    2000 mg/day
  • Drug: ribavirin
    1000-1200 mg/day
  • Drug: Peginterferon alfa-2a
    Peginterferon alfa-2a 180 mcg/week
  • Drug: epoetin beta
    epoetin beta 450 UI/week
  • Experimental: 1
    Peginterferon alfa-2a 180 mcg/week + ribavirin 2000 mg/day + epoetin beta 450 UI/week
    Interventions:
    • Drug: ribavirin
    • Drug: Peginterferon alfa-2a
    • Drug: epoetin beta
  • Active Comparator: 2
    Peginterferon alfa-2a 180 mcg/week + ribavirin 1000-1200 mg/day
    Interventions:
    • Drug: ribavirin
    • Drug: Peginterferon alfa-2a
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
384
February 2010
Not Provided

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
Both
18 Years to 75 Years
No
Contact: Vicente Soriano, Dr +34914532500 vsoriano@dragonet.es
Contact: Pablo Barreiro, Dr +34914532500 pbarreiro@v4066.drago.net
Spain
 
NCT00526448
2006-005940-99
Yes
Not Provided
Hospital Carlos III, Madrid
Not Provided
Study Chair: Vicente Soriano, Dr Hospital Carlos III. Madrid. Spain
Hospital Carlos III, Madrid
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP