HIV Infections Clinical Trial
Official title:
PEG-Interferon a-2b + Ribavirin for Treatment of Chronic Hepatitis C Infection in HIV-Infected Persons Not Previously Treated With Interferon
Objectives:
Primary To compare the sustained virologic response (SVR) of PEGIntron plus ribavirin among
patients receiving 48 weeks versus 72 weeks of therapy (defined as undetectable HCV RNA
level 24 weeks after discontinuing therapy).
Secondary
- To evaluate the safety and tolerability PEG Intron in combination with ribavirin for
treatment of Chronic Hepatitis C (CHC) infection in patients co-infected with Human
Immunodeficiency Virus (HIV).
- To determine the early virologic response of patients receiving PEGIntron plus
ribavirin at Treatment Week 24
Study Design:
All qualifying patients will enter the treatment phase and be dosed as follows:
Peginterferon a-2b 1.5mg/kg by subcutaneous route once weekly plus
Ribavirin:
- 800 mg (400 mg bid) if body weight < 65 kg
- 1000 mg (400 mg a.m. and 600 mg p.m.) if body weight > 65 kg and < 85 kg
- 1200 mg (600 mg bid) if body weight > 85 kg and < 105 kg
- 1400 mg (600 mg a.m. and 800 mg p.m.) if body weight > 105 kg
At Treatment Week 24, all participants with detectable HCV-RNA will be discontinued from
treatment and followed for a Post Treatment period of 24 weeks. Participants with
undetectable HCV-RNA values at Treatment Week 24 will be randomized to either:
- Group A: an additional 24 weeks of previously assigned Peginterferon a-2b + Ribavirin
therapy, for a total of 48 weeks of treatment.
- Group B: an additional 48 weeks of previously assigned Peginterferon a-2b + Ribavirin
therapy, for a total of 72 weeks of treatment.
Study Population:
300 HIV infected adults with chronic hepatitis C infection who have not been treated
previously with interferon therapy.
Dosage and Administration:
Peginterferon a-2b 1.5mg/kg by subcutaneous route once weekly plus
Ribavirin:
- 800 mg (400 mg bid) if body weight < 65 kg
- 1000 mg (400 mg a.m. and 600 mg p.m.) if body weight > 65 kg and < 85 kg
- 1200 mg (600 mg bid) if body weight > 85 kg and < 105 kg
- 1400 mg (600 mg a.m. and 800 mg p.m.) if body weight > 105 kg
Efficacy Evaluations:
Laboratory analysis, liver biopsies, quality of life assessments, and changes in
Peginterferona-2b and Ribavirin dosages will be obtained.
Safety Evaluations:
- Assessment of laboratory evaluations
- vital signs
- incidence and severity of adverse experiences
- dose adjustments
- premature withdrawal for safety reasons
- progression of disease as measured by HCV viral load
- AIDS defining events
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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