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

July 25, 2006
September 2, 2009
October 2005
March 2009   (final data collection date for primary outcome measure)
Percentage of patients with undetectable RNA-HCV [ Time Frame: at week 12 after starting treatment ] [ Designated as safety issue: Yes ]
Percentage of patients with undetectable RNA-HCV at week 12 after starting treatment.
Complete list of historical versions of study NCT00356486 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Variations of the levels of RNA-HCV from baseline until weeks 4, 8 and 12 of the study.
  • Percentage of patients with undetectable HCV RNA in weeks 4 and 8 of the study.
  • Levels of ALT after 4, 8 and 12 weeks.
  • Percentage of patients that must reduce the dose of peginterferon alpha-2a (40 KD) and Ribavirin.-Percentage of patients that drop out of the study for adverse effects or intolerance.
  • Variations in levels of haemoglobin, neutrophil and platelet count at 4, 8 and 12 weeks with regard to baseline.
  • AIDS-defining events or death.
  • Changes in the CD4/CD8 cell count after 4, 8 and 12 weeks.
Not Provided
Not Provided
 
Viral Kinetics of Treatment With Peginterferon Alpha-2a, Ribavirin and Epoetin β in Patients Coinfected HCV/HIV
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)

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • 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
  • 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
  • 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
    Intervention: Drug: Peginterferon alfa-2a, Ribavirin, epoetin-β
  • Experimental: B
    Peginterferon alfa-2a (40 KD) (180 µg/week) subcutaneous + Ribavirin(1000-1200 mg/day) oral/day for 12 weeks
    Intervention: Drug: Peginterferon alfa-2a + Ribavirin for 12 weeks
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
74
March 2009
March 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00356486
CORAL-2, 2004 - 000907 -16
No
Lluita Sida Foundation
Germans Trias i Pujol Hospital
Fundacio Lluita Contra la SIDA
Principal Investigator: Bonaventura Clotet, MD, PhD LLuita contra la Sida Foundation-HIV Unit
Germans Trias i Pujol Hospital
September 2009

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