Treatment of Chronic Hepatitis C With PEG Interferon alfa2a and Ribavirin in HIV-Infected Patients

Efficacy and Safety of Peginterferon alfa2a and Ribavirin for the Second Line Treatment of Chronic Hepatitis C in HIV Infected Patients Previously Non Responders to a First Anti-HCV Treatment

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00221650

Acronym

ROCO2

Enrollment

Registered

2005-09-22

Start date

2002-04-30

Completion date

2004-06-30

Last updated

2007-06-13

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

Conditions

HIV Infections, Hepatitis C, Chronic, Treatment Failure

Keywords

Hepatitis C, Chronic, HCV infection, HIV infection, Treatment Failure, PEG interferon, Interferons/therapeutic use, Interferon Alfa-2a/adverse effects, Ribavirin/therapeutic use, Ribavirin/adverse effects, Drug Therapy, Combination, Treatment Experienced, Treatment Naive

Brief summary

Combination of PEG interferon and ribavirin is the standard treatment of chronic hepatitis C. Efficacy of this treatment has never been evaluated in HCV-HIV infected patients, who have previously been treated with a first line anti-HCV treatment. The purpose of the study is to evaluate the combination PEG interferon alfa2a-ribavirin in HIV-infected patients with chronic hepatitis C pretreated with interferon alone or interferon combined with ribavirin. The patients receive a dose of 180 µg of PEGASYS once a week and 800 to 1200 mg/day of ribavirin (according to weight) for 48 weeks. Primary outcome of the study is a sustained virological response, defined as an undetectable HCV RNA level 24 weeks after the end of anti-HCV treatment.

Interventions

DRUGPeginterferon alfa2a

DRUGRibavirin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Chronic hepatitis C : Detectable HCV RNA, Previously treated with interferon or interferon combined with ribavirin, Elevated ALT level * HIV infection (CD4\>250/µL, HIV RNA\<10 000 copies/ml) treated or not with antiretroviral therapy * Signed informed consent

Exclusion criteria

* Chronic hepatitis B * Alcohol consumption\>40g/day * Evidence of decompensated liver disease * Hepatocellular carcinoma * Other relevant disorders: organ transplantation, psychiatric or cardiovascular disease, poorly controlled diabetes, seizure disorders, hemoglobinopathy, autoimmune disease

Design outcomes

Primary

Measure	Time frame
Proportion of patients with a sustained virological response, defined as an undetectable HCV RNA level	24 weeks after the end of anti-HCV treatment

Secondary

Measure	Time frame
Proportion of patients with a virological response	at weeks 24 and 48
Safety of treatment	—
Influence of anti-HCV treatment on CD4 count and HIV RNA	—
Proportion of patients with histological response 24 weeks after the end of anti-HCV treatment	—

Countries

France

Outcome results

None listed

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