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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00470210
First Posted: May 7, 2007
Last Update Posted: April 16, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fundacio Lluita Contra la SIDA
Information provided by:
Germans Trias i Pujol Hospital
  Purpose
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.

Condition Intervention Phase
Hepatitis C HIV Infections Drug: Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week Drug: Ribavirin (Copegus®) 1600 mg/day Drug: Epoetin β (450 UI/kg/week) Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Rate of sustained virologic response measured as serum HCV-RNA loads of < 50 IU/mL [ Time Frame: 24 weeks after finishing treatment ]

Secondary Outcome Measures:
  • Changes in serum HCV-RNA titers [ Time Frame: 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 [ Time Frame: at weeks 4, 8, 12, 24, and 48 ]

Enrollment: 10
Study Start Date: May 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week Ribavirin (Copegus®) 1600 mg/day Epoetin β (450 UI/kg/week)
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)

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00470210


Locations
Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Hospital del Mar
Barcelona, Spain, 08003
Sponsors and Collaborators
Germans Trias i Pujol Hospital
Fundacio Lluita Contra la SIDA
Investigators
Principal Investigator: Bonaventura Clotet, MD, PhD Germans Trias i Pujol Hospital
Principal Investigator: Cristina Tural, MD, PhD Germans Trias i Pujol Hospital
  More Information

Responsible Party: LLuita Sida Foundation
ClinicalTrials.gov Identifier: NCT00470210     History of Changes
Other Study ID Numbers: MORE
2006-005554-74
First Submitted: May 4, 2007
First Posted: May 7, 2007
Last Update Posted: April 16, 2010
Last Verified: April 2010

Keywords provided by Germans Trias i Pujol Hospital:
Ribavirin
non-responders
HCV co-infected patients
sustained virological response
Treatment Experienced

Additional relevant MeSH terms:
Hepatitis C
HIV Infections
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Epoetin Alfa
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Hematinics
Immunologic Factors
Physiological Effects of Drugs