Peginterferon Alfa-2a, Ribavirin and Epoetin β in Coinfected Patients HCV/HIV Not Responding to Previous Treatment Regimens

This study has been completed.
Sponsor:
Collaborator:
Fundacio Lluita Contra la SIDA
Information provided by:
Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier:
NCT00470210
First received: May 4, 2007
Last updated: April 15, 2010
Last verified: April 2010

May 4, 2007
April 15, 2010
May 2007
June 2009   (final data collection date for primary outcome measure)
Rate of sustained virologic response measured as serum HCV-RNA loads of < 50 IU/mL [ Time Frame: 24 weeks after finishing treatment ] [ Designated as safety issue: No ]
Rate of sustained virologic response measured as serum HCV-RNA loads of < 50 IU/mL 24 weeks after finishing treatment.
Complete list of historical versions of study NCT00470210 on ClinicalTrials.gov Archive Site
  • Changes in serum HCV-RNA titers [ Time Frame: between baseline and 4, 8, 12, 24, and 48 weeks after start of treatment ] [ Designated as safety issue: No ]
  • Percentage of patients with serum HCV-RNA loads of < 50 IU/mL [ Time Frame: at weeks 4, 8, 12, 24, and 48 ] [ Designated as safety issue: Yes ]
Changes in serum HCV-RNA titers between baseline and 4, 8, 12, 24, and 48 weeks after start of treatment. Percentage of patients with serum HCV-RNA loads of < 50 IU/mL at weeks 4, 8, 12, 24, and 48.
Not Provided
Not Provided
 
Peginterferon Alfa-2a, Ribavirin and Epoetin β in Coinfected Patients HCV/HIV Not Responding to Previous Treatment Regimens
Efficacy and Safety of High-dose Ribavirin (1600 mg/d) Boosted With Epoetin β (450 IU/kg/wk) in HIV/HCV Coinfected Patients Not Responding to Previous Treatment Regimens

This trial will assess the sustained virologic response to treatment with peginterferon alfa-2a combined with high-dose ribavirin in human immunodeficiency virus (HIV)-infected patients with hepatitis C virus (HCV) genotype 1 or 4 coinfection and persistent transaminase elevations. These patients will have been nonresponders to previous regimens with peginterferon alfa and ribavirin therapy at a dosage of 800-1200 mg/d.

The purpose in treating chronic HCV infection in HIV-coinfected individuals is to clear HCV-RNA antibodies and cure the infection. Studies have shown that high doses of ribavirin are associated with higher response rates than those achieved with ribavirin at dosages of 800-1200 mg/d.

The main aim of this trial is to assess the sustained virologic response to treatment with peginterferon alfa-2a plus high-dose ribavirin in HIV-infected patients coinfected with HCV genotypes 1 or 4 who have had persistent transaminase elevations and lack of response to previous treatment with peginterferon alfa and ribavirin at dosages of 800-1200 mg/d.

The second aim will be to measure changes in serum HCV-RNA titers and the percentage of patients achieving serum viral loads of < 50 IU/mL during treatment. Finally, we also intend to evaluate the safety of this treatment regimen.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hepatitis C
  • HIV Infections
  • Drug: Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week
    Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week
  • Drug: Ribavirin (Copegus®) 1600 mg/day
    Ribavirin (Copegus®) 1600 mg/day
  • Drug: Epoetin β (450 UI/kg/week)
    Epoetin β (450 UI/kg/week)
Experimental: 1
Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week Ribavirin (Copegus®) 1600 mg/day Epoetin β (450 UI/kg/week)
Interventions:
  • Drug: Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week
  • Drug: Ribavirin (Copegus®) 1600 mg/day
  • Drug: Epoetin β (450 UI/kg/week)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
June 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV-infected patients coinfected with HCV genotypes 1 or 4
  • Persistent transaminase elevation
  • Nonresponders to previous treatment with peginterferon alfa plus ribavirin at a dosage of 800-1200 mg/d.

Exclusion Criteria:

  • Patients who abandoned treatment with peginterferon plus ribavirin before 12 weeks
  • Patients with Child-Pugh B or C cirrhosis
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00470210
MORE, 2006-005554-74
No
LLuita Sida Foundation
Germans Trias i Pujol Hospital
Fundacio Lluita Contra la SIDA
Principal Investigator: Bonaventura Clotet, MD, PhD HOSPITAL GERMANS TRIAS I PUJOL
Principal Investigator: Cristina Tural, MD, PhD HOSPITAL GERMANS TRIAS I PUJOL
Germans Trias i Pujol Hospital
April 2010

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