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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ 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 ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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: 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 HOSPITAL GERMANS TRIAS I PUJOL
Principal Investigator: Cristina Tural, MD, PhD HOSPITAL GERMANS TRIAS I PUJOL
  More Information

No publications provided

Responsible Party: LLuita Sida Foundation
ClinicalTrials.gov Identifier: NCT00470210     History of Changes
Other Study ID Numbers: MORE, 2006-005554-74
Study First Received: May 4, 2007
Last Updated: April 15, 2010
Health Authority: Spain: Ministry of Health

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Hepatitis
Hepatitis A
Hepatitis C
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
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Epoetin alfa
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014