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

Sponsors and Collaborators:	Germans Trias i Pujol Hospital FUNDACIÓ LLUITA CONTRA LA SIDA
Information provided by:	Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier:	NCT00470210

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 IV

MedlinePlus related topics: AIDS Hepatitis Hepatitis C

Drug Information available for: Epoetin alfa Erythropoietin Ribavirin Peginterferon Alfa-2a

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

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
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00470210

Locations

Spain
Hospital del Mar
Barcelona, Spain, 08003
Spain, Barcelona
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916

Sponsors and Collaborators

Germans Trias i Pujol Hospital

FUNDACIÓ 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

Responsible Party:	LLuita Sida Foundation ( LLuita Sida Foundation )
Study ID Numbers:	MORE, 2006-005554-74
Study First Received:	May 4, 2007
Last Updated:	September 3, 2008
ClinicalTrials.gov Identifier:	NCT00470210
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

Study placed in the following topic categories:

Interferon-alpha
Epoetin Alfa
Sexually Transmitted Diseases, Viral
Liver Diseases
Interferons
Acquired Immunodeficiency Syndrome
Ribavirin
Hepatitis, Viral, Human
Immunologic Deficiency Syndromes

Hepatitis
Virus Diseases
Digestive System Diseases
HIV Infections
Sexually Transmitted Diseases
Peginterferon alfa-2a
Hepatitis C
Interferon Alfa-2a
Retroviridae Infections

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Flaviviridae Infections
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances

Physiological Effects of Drugs
Infection
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Therapeutic Uses
Lentivirus Infections
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on January 14, 2009