Phase IV Study to Evaluate the Efficacy/Safety to Extend Treatment and High Dose of Ribavirin in co-Infected Patients

Chronic Hepatitis C Clinical Trial

— PERICO  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00526448
• Other study ID #: 2006-005940-99
• Status: Recruiting
• Phase: Phase 4
• First received: September 5, 2007
• Last updated: January 28, 2009
• Start date: June 2007
• Est. completion date: February 2010

Study information

• Verified date: January 2009
• Source: Hospital Carlos III, Madrid
• Contact: Vicente Soriano, Dr
• Phone: +34914532500
• Email: vsoriano[@]dragonet.es
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 384
• Est. completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Spain	Hospital Juan Canalejo	A Coruña
Spain	Hospital de Albacete	Albacete
Spain	Hospital de Alcorcon	Alcorcon	Madrid
Spain	Hospital de Cruces	Baracaldo	Vizcaya
Spain	Hospital Santa Creu y Sant Pau	Barcelona
Spain	Hospital General de Elche	Elche	Alicante
Spain	Hospital Arquitecto Marcide	Ferrol	La Coruña
Spain	Hospital Clínico san Cecilio	Granada
Spain	Hospital San Jorge	Huesca
Spain	Hospital General de Jerez de la Frontera	Jerez de la Frontera	Cadiz
Spain	Hospital Universitario de Canarias	La Laguna	Santa Cruz de Tenerife
Spain	Hospital General de la Palma	La Palma	Santa Cruz de Tenerife
Spain	Hospital Doctor Negrín	Las Palmas de Gran Canarias	Gran Canaria
Spain	Hospital Severo Ochoa	Leganés	Madrid
Spain	Hospital Xeral-Caldé	Lugo
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital Carlos III	Madrid
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital de la Princesa	Madrid
Spain	Hospital Gregorio Marañón	Madrid
Spain	Hospital Clínico Virgen de la Victoria	Málaga
Spain	Hospital Santa Maria del Rosell	Murcia
Spain	Hospital Central de Asturias	Oviedo	Asturias
Spain	Hospital Son Dureta	Palma de Mallorca	Baleares
Spain	Hospital General de Fuerteventura	Puerto del Rosario	Fuerteventura
Spain	Hospital Parc Taulí	Sabadell	Barcelona
Spain	Hospital Clínico de Salamanca	Salamanca
Spain	Hospital de la Candelaria	Santa Cruz de Tenerife
Spain	Hospital Marqués de Valdecilla	Santander	Cantabria
Spain	Hospital Clínico Universitario	Santiago	La Coruña
Spain	Hospital de Valme	Sevilla
Spain	Hospital Virgen de la Macarena	Sevilla
Spain	Hospial Clinico Universitario de Valencia	Valencia
Spain	Hospital Universitario la Fé	Valencia
Spain	Hospital Clínico de Valladolid	Valladolid
Spain	Hospital do Meixoeiro	Vigo	Pontevedra
Spain	Hospital Xeral-Cíes	Vigo	Pontevedra
Spain	Hospital Txagorritxu	Vitoria	Alava
Spain	Hospital Clínico Universitario Lozano Blesa	Zaragoza
Spain	Hospital Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Carlos III, Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% patients with RNA-HCV < 50 UI/ml		24 weeks after the end of treatment
Secondary	% patients with RNA-HCV < 50 UI/ml		4 weeks on treatment