Skip to main content
OpenTrials
Completed

NCT Number: NCT00470210

Peginterferon Alfa-2a, Ribavirin and Epoetin β in Coinfected Patients HCV/HIV 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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

Ribavirin (Copegus®) 1600 mg/day

Drug

Ribavirin (Copegus®) 1600 mg/day

Epoetin β (450 UI/kg/week)

Drug

Epoetin β (450 UI/kg/week)

Primary outcomes

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

    Time frame: 24 weeks after finishing treatment

Secondary outcomes

  1. Changes in serum HCV-RNA titers

    Time frame: between baseline and 4, 8, 12, 24, and 48 weeks after start of treatment

  2. Percentage of patients with serum HCV-RNA loads of < 50 IU/mL

    Time frame: at weeks 4, 8, 12, 24, and 48

Sponsors and collaborators

Lead sponsor

Germans Trias i Pujol Hospital

Other

Collaborators

  • Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
May 7, 2007
Registry last updated
Dec 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.