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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00470210

Enrollment

Registered

2007-05-07

Start date

2007-05-31

Completion date

2009-06-30

Last updated

2019-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, HIV Infections

Keywords

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

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.

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.

Interventions

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

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

DRUGRibavirin (Copegus®) 1600 mg/day

Ribavirin (Copegus®) 1600 mg/day

DRUGEpoetin β (450 UI/kg/week)

Epoetin β (450 UI/kg/week)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Rate of sustained virologic response measured as serum HCV-RNA loads of < 50 IU/mL	24 weeks after finishing treatment

Secondary

Measure	Time frame
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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026