Viral Kinetics of Treatment With Peginterferon Alpha-2a, Ribavirin and Epoetin β in Patients Coinfected HCV/HIV - Full Text View

Sponsors and Collaborators:	Germans Trias i Pujol Hospital FUNDACIÓ LLUITA CONTRA LA SIDA
Information provided by:	Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier:	NCT00356486

Purpose

The purpose of this study is to compare the early virological response (EVR = undetectable [ribonucleic acid-hepatitis C virus] RNA-HCV or a reduction of > 2 log10) of patients with chronic hepatitis C coinfected with HIV treated with induction doses of peginterferon alpha-2a (40 KD) 270 µg/week and ribavirin 1600 mg/day for 4 weeks, followed by 8 weeks of treatment with peginterferon alpha-2a (40 KD) 180 µg/week and ribavirin 1000-1200 mg/day versus treatment with peginterferon alpha-2a (40 KD) 180 µg/week and ribavirin 1000-1200 mg/day for 12 weeks.

Condition	Intervention	Phase
HIV Infections	Drug: Peginterferon alfa-2a, Ribavirin, epoetin-β Drug: Peginterferon alfa-2a + Ribavirin for 12 weeks	Phase IV

MedlinePlus related topics: AIDS Hepatitis Hepatitis C

Drug Information available for: Epoetin alfa Erythropoietin Ribavirin Peginterferon Alfa-2a

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Open, Multicentre and Randomised Phase IV Study to Evaluate Viral Kinetics in the First 12 Weeks of Patients With Chronic Hepatitis C Genotypes 1 and 4 Coinfected by the Human Immunodeficiency Virus Treated With Induction Doses of Peginterferon Alpha-2a (40 KD) (270 μg/Week) and Ribavirin (1600 mg/Day) With Epoetin β Support (450 IU/kg/Week)

Further study details as provided by Germans Trias i Pujol Hospital:

Primary Outcome Measures:

Percentage of patients with undetectable RNA-HCV [ Time Frame: at week 12 after starting treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Variations of the levels of RNA-HCV [ Time Frame: from baseline until weeks 4, 8, and 12 of the study ] [ Designated as safety issue: No ]
Percentage of patients with undetectable HCV RNA [ Time Frame: in weeks 4 and 8 of the study ] [ Designated as safety issue: No ]
Levels of ALT [ Time Frame: At weeks 4, 8, and 12 ] [ Designated as safety issue: No ]
Percentage of patients that must reduce the dose of peginterferon alpha-2a (40 KD) and ribavirin. [ Time Frame: During the 12 weeks of follow-up ] [ Designated as safety issue: No ]
Percentage of patients that drop out of the study for adverse effects or intolerance [ Time Frame: During the 12 weeks of follow-up ] [ Designated as safety issue: No ]
Variations in levels of haemoglobin, neutrophil, and platelet count [ Time Frame: at 4, 8, and 12 weeks with regard to baseline ] [ Designated as safety issue: No ]
AIDS-defining events or death [ Time Frame: During the 12 weeks of follow-up ] [ Designated as safety issue: No ]
Changes in the CD4/CD8 cell count [ Time Frame: At 4, 8, and 12 weeks of follow-up ] [ Designated as safety issue: No ]

Enrollment:	74
Study Start Date:	October 2005
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Peginterferon alfa-2a (40 KD) (270 µg/week) + Ribavirin (1600 mg/day) + epoetin-β (450 UI/kg/week) for 4 weeks. Peginterferon alfa-2a (40 KD) (180 µg/week) + Ribavirin (1000-1200 mg/day) for 8 weeks	Drug: Peginterferon alfa-2a, Ribavirin, epoetin-β Peginterferon alfa-2a(270 µg/week) + Ribavirin (1600 mg/day) + epoetin-β (450 UI/kg/week) for 4 weeks. Peginterferon alfa-2a (180 µg/week) + Ribavirin(1000-1200 mg/day) for 8 weeks
B: Experimental Peginterferon alfa-2a (40 KD) (180 µg/week) subcutaneous + Ribavirin(1000-1200 mg/day) oral/day for 12 weeks	Drug: Peginterferon alfa-2a + Ribavirin for 12 weeks Peginterferon alfa-2a (40 KD) (180 µg/week) subcutaneous + Ribavirin(1000-1200 mg/day) oral/day for 12 weeks

Detailed Description:

This study seeks to ascertain whether treatment with higher doses of PEGASYS (270 µg/week) and ribavirin (1600 mg/day) for the first four weeks achieves the plasma concentrations of the product in the blood needed to reduce the half-life of the virions and accelerate the elimination thereof. This would bring the viral kinetic curves in coinfected patients closer to the model described for mono-infected HCV patients, probably achieving improved rates of response in week 12 (early virological response) and posterior in week 72 (sustained virological response).

Therefore, the patients were randomised to treatment with two different doses, 270 µg and 180 µg of PEGASYS, and 1600 mg and 1000-1200 mg of ribavirin.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Serological evidence of chronic hepatitis C infection in an anti-HCV antibody test
Detectable RNA-HCV plasma level genotype 1 and 4
ALT serum activity above the upper limit of normality
Chronic liver disease consistent with chronic hepatitis C infection in a biopsy obtained during the two years prior to inclusion in the study
Serological evidence of HIV-1 infection, diagnosed by Enzyme-Linked Immunosorbent Assay (ELISA) and confirmed by Western-blot.
Patients with CD4 cell count > 200 /µl
Stable status in HIV-1 infection, in the investigator's opinion, in other words, patients that are not expected to progress during the study.
Patients treated with stable anti-retroviral therapy (HAART), which does not include nucleoside analogues, for at least 6 weeks before the baseline assessment
Patients that do not receive HAART therapy
Negative pregnancy test in urine or blood

Exclusion Criteria:

Women currently pregnant or in the lactation period.
Patients whose companion is pregnant.
Therapy with interferon (IFN) or ribavirin at any previous time.
Patients with cirrhosis in the hepatic biopsy.
Documented suspicion by ultrasound of hepatocarcinoma.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00356486

Locations

Spain
Hospital General Universitario de Alicante
Alicante, Spain, 46014
Hospital del Mar
Barcelona, Spain, 08003
Hospital Clínic i Provincial
Barcelona, Spain, 08036
Hospital Ramón y Cajal
Madrid, Spain, 28007
Hospital La Paz
Madrid, Spain, 28046
Hospital Puerta del Mar
Cádiz, Spain, 11009
Hospital Gregorio Marañón.
Madrid, Spain, 28007
Hospital Clínico San Carlos
Madrid, Spain, 28040
Spain, Barcelona
Hospital Germans Trias i Pujol, Badalona
Badalona, Barcelona, Spain, 08916
Hospital General de Vic
Vic, Barcelona, Spain, 08500
Consorci Sanitari de Terrassa
Terrassa, Barcelona, Spain, 08221
Spain, Donostia
Hospital de Donostia
San Sebastián, Donostia, Spain, 20012

Sponsors and Collaborators

Germans Trias i Pujol Hospital

FUNDACIÓ LLUITA CONTRA LA SIDA

Investigators

Principal Investigator:

Bonaventura Clotet, MD, PhD

LLuita contra la Sida Foundation-HIV Unit

More Information

Responsible Party:	Lluita Sida Foundation ( Lluita Sida Foundation )
Study ID Numbers:	CORAL-2, 2004 - 000907 -16
Study First Received:	July 25, 2006
Last Updated:	November 5, 2008
ClinicalTrials.gov Identifier:	NCT00356486
Health Authority:	Spain: Ministry of Health

Keywords provided by Germans Trias i Pujol Hospital:

Chronic Hepatitis C
Co-infection
Induction dose
HIV
HIV Infections

Study placed in the following topic categories:

Interferon-alpha
Epoetin Alfa
Sexually Transmitted Diseases, Viral
Liver Diseases
Hepatitis, Chronic
Interferons
Ribavirin
Acquired Immunodeficiency Syndrome
Hepatitis, Viral, Human
Immunologic Deficiency Syndromes

Hepatitis
Virus Diseases
Digestive System Diseases
HIV Infections
Sexually Transmitted Diseases
Peginterferon alfa-2a
Hepatitis C
Interferon Alfa-2a
Hepatitis C, Chronic
Retroviridae Infections

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Flaviviridae Infections
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances

Physiological Effects of Drugs
Infection
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Therapeutic Uses
Lentivirus Infections
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on January 16, 2009