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

NCT00470210 | Completed Phase 4

• 2 other identifiers: MORE2006-005554-74
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hepatitis C; HIV Infections

Keywords

Ribavirin; non-responders; HCV co-infected patients; sustained virological response; Treatment Experienced

Outcome Measures

Primary Outcomes (1)

• Rate of sustained virologic response measured as serum HCV-RNA loads of < 50 IU/mL

  24 weeks after finishing treatment

Secondary Outcomes (2)

• 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

Study Arms (1)

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; Drug: Ribavirin (Copegus®) 1600 mg/day; Drug: Epoetin β (450 UI/kg/week)

Interventions

Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week DRUG

Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week

1

Ribavirin (Copegus®) 1600 mg/day DRUG

Ribavirin (Copegus®) 1600 mg/day

1

Epoetin β (450 UI/kg/week) DRUG

Epoetin β (450 UI/kg/week)

1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients who abandoned treatment with peginterferon plus ribavirin before 12 weeks
• Patients with Child-Pugh B or C cirrhosis

Sponsors & Collaborators

• Germans Trias i Pujol Hospital: lead
• Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia: collaborator

Study Sites (2)

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

MeSH Terms

Conditions

Hepatitis C; HIV Infections

Interventions

peginterferon alfa-2a; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Bonaventura Clotet, MD, PhD

  Germans Trias i Pujol Hospital

  PRINCIPAL INVESTIGATOR

• Cristina Tural, MD, PhD

  Germans Trias i Pujol Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2007
• First Posted: May 7, 2007
• Study Start: May 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: December 5, 2019

Record last verified: 2019-12

Locations

ES (2)