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

This study has been completed.
Sponsor:
Collaborator:
Fundacio Lluita Contra la SIDA
Information provided by:
Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier:
NCT00356486
First received: July 25, 2006
Last updated: September 2, 2009
Last verified: September 2009
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


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
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
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
Experimental: B
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
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: NCT00356486

Locations
Spain
Hospital Germans Trias i Pujol, Badalona
Badalona, Barcelona, Spain, 08916
Consorci Sanitari de Terrassa
Terrassa, Barcelona, Spain, 08221
Hospital General de Vic
Vic, Barcelona, Spain, 08500
Hospital de Donostia
San Sebastián, Donostia, Spain, 20012
Hospital General Universitario de Alicante
Alicante, Spain, 46014
Hospital Clínic i Provincial
Barcelona, Spain, 08036
Hospital del Mar
Barcelona, Spain, 08003
Hospital Puerta del Mar
Cádiz, Spain, 11009
Hospital Clínico San Carlos
Madrid, Spain, 28040
Hospital La Paz
Madrid, Spain, 28046
Hospital Ramón y Cajal
Madrid, Spain, 28007
Hospital Gregorio Marañón.
Madrid, Spain, 28007
Sponsors and Collaborators
Germans Trias i Pujol Hospital
Fundacio Lluita Contra la SIDA
Investigators
Principal Investigator: Bonaventura Clotet, MD, PhD LLuita contra la Sida Foundation-HIV Unit
  More Information

No publications provided

Responsible Party: Lluita Sida Foundation
ClinicalTrials.gov Identifier: NCT00356486     History of Changes
Other Study ID Numbers: CORAL-2, 2004 - 000907 -16
Study First Received: July 25, 2006
Last Updated: September 2, 2009
Health Authority: Spain: Ministry of Health

Keywords provided by Germans Trias i Pujol Hospital:
Chronic Hepatitis C
Co-infection
Induction dose
HIV
HIV Infections

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Hepatitis C, Chronic
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Hepatitis C
Hepatitis, Viral, Human
Flaviviridae Infections
Hepatitis, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Epoetin alfa
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on October 01, 2014