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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00470210
• Other study ID #: MORE
• Secondary ID: 2006-005554-74
• Status: Completed
• Phase: Phase 4
• Start date: May 2007
• Est. completion date: June 2009

Study information

• Verified date: December 2019
• Source: Germans Trias i Pujol Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis C
• HIV Infections

Intervention

Drug:
• Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week
Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week
• Ribavirin (Copegus®) 1600 mg/day
Ribavirin (Copegus®) 1600 mg/day
• Epoetin ß (450 UI/kg/week)
Epoetin ß (450 UI/kg/week)

Locations

Country	Name	City	State
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital del Mar	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Germans Trias i Pujol Hospital	Fundacio Lluita Contra la SIDA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of sustained virologic response measured as serum HCV-RNA loads of < 50 IU/mL		24 weeks after finishing treatment
Secondary	Changes in serum HCV-RNA titers		between baseline and 4, 8, 12, 24, and 48 weeks after start of treatment
Secondary	Percentage of patients with serum HCV-RNA loads of < 50 IU/mL		at weeks 4, 8, 12, 24, and 48