Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00215839
Status:
UNKNOWN
Last Update Posted:
2005-10-25
First Post:
2005-09-20
Brief Title:
HRN 004- Peginterferon a-2a Plus Ribavirin for Chronic Hepatitis C Infection in HIV Infected Persons Who Have Failed to Achieve a Sustained Virologic Response Following Previous Interferon Therapy
Sponsor:
Hepatitis Resource Network
Organization:
Hepatitis Resource Network
Study Overview
Official Title:
A Multi-Center Randomized Open-Label Phase IIIb Study Investigating the Safety and Efficacy of Peginterferon a-2a Plus Ribavirin for the Treatment of Chronic Hepatitis C Infection in HIV Infected Persons Who Have Failed to Achieve a Sustained Virologic Response Following Previous Interferon Therapy
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objectives
Primary To evaluate the safety tolerability and efficacy of Peginterferon a-2a plus Ribavirin for the treatment of chronic hepatitis C CHC infection in persons co-infected with human immunodeficiency virus HIV who have failed to achieve a sustained virologic response following previous interferon therapy
Secondary
To evaluate the virological response to Peginterferon a-2a plus Ribavirin at weeks 12 and 24 as compared to baseline values
To evaluate the sustained virological response Peginterferon a-2a plus Ribavirin at post-treatment weeks 4 12 and 24 as compared to baseline
To evaluate the histological effects of long-term Peginterferon a-2a therapy through comparison of liver biopsy results following 96 weeks of Peginterferon a-2a therapy to baseline values
To evaluate the safety and tolerability of long-term Peginterferon a-2a therapy in patients who have previously failed to achieve a sustained virologic response following interferon therapy
To investigate the effects of long-term Peginterferon a-2a therapy on clinical outcomes of HIV disease
Study Design
All qualifying patients will enter the treatment phase and be dosed as follows
Peginterferon a-2a 180mg by subcutaneous route once weekly plus
Ribavirin
800 mg 400 mg bid if body weight 65 kg
1000 mg 400 mg am and 600 mg pm if body weight 65 kg and 85 kg
1200 mg 600 mg bid if body weight 85 kg
Patients with undetectable levels of HCV-RNA at Treatment Week 24 will continue on previously assigned Peginterferon a-2a plus Ribavirin combo-therapy for an additional 24 weeks Patients with detectable levels of HCV-RNA will be randomized to Peginterferon a-2a mono-therapy or no treatment for 72 weeks
Group A Peginterferon a-2a 90mg mono-therapy for 72 weeks
Group B No CHC therapy for 72 weeks
All patients entering the study are required to have a baseline liver biopsy within 18 months of study entry Patients entering the 72-week randomized arm of the trial will have a post-study liver biopsy upon completion of the trial
Study Population
100 HIV infected adults with chronic hepatitis C infection who have failed to achieve a sustained virologic response following previous interferon therapy
Dosage and Administration
Combo-therapy Peginterferon a-2a 180mg by subcutaneous route once weekly plus
Ribavirin
800 mg 400 mg bid if body weight 65 kg
1000 mg 400 mg am and 600 mg pm if body weight 65 kg and 85 kg
1200 mg 600 mg bid if body weight 85 kg Mono-therapy Peginterferon a-2a 90mg in 1mL solution administered subcutaneously once weekly
Efficacy Evaluations
Laboratory analysis liver biopsies quality of life assessments and changes in Peginterferona-2a 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
Primary To evaluate the safety tolerability and efficacy of Peginterferon a-2a plus Ribavirin for the treatment of chronic hepatitis C CHC infection in persons co-infected with human immunodeficiency virus HIV who have failed to achieve a sustained virologic response following previous interferon therapy
Secondary
To evaluate the virological response to Peginterferon a-2a plus Ribavirin at weeks 12 and 24 as compared to baseline values
To evaluate the sustained virological response Peginterferon a-2a plus Ribavirin at post-treatment weeks 4 12 and 24 as compared to baseline
To evaluate the histological effects of long-term Peginterferon a-2a therapy through comparison of liver biopsy results following 96 weeks of Peginterferon a-2a therapy to baseline values
To evaluate the safety and tolerability of long-term Peginterferon a-2a therapy in patients who have previously failed to achieve a sustained virologic response following interferon therapy
To investigate the effects of long-term Peginterferon a-2a therapy on clinical outcomes of HIV disease
Study Design
All qualifying patients will enter the treatment phase and be dosed as follows
Peginterferon a-2a 180mg by subcutaneous route once weekly plus
Ribavirin
800 mg 400 mg bid if body weight 65 kg
1000 mg 400 mg am and 600 mg pm if body weight 65 kg and 85 kg
1200 mg 600 mg bid if body weight 85 kg
Patients with undetectable levels of HCV-RNA at Treatment Week 24 will continue on previously assigned Peginterferon a-2a plus Ribavirin combo-therapy for an additional 24 weeks Patients with detectable levels of HCV-RNA will be randomized to Peginterferon a-2a mono-therapy or no treatment for 72 weeks
Group A Peginterferon a-2a 90mg mono-therapy for 72 weeks
Group B No CHC therapy for 72 weeks
All patients entering the study are required to have a baseline liver biopsy within 18 months of study entry Patients entering the 72-week randomized arm of the trial will have a post-study liver biopsy upon completion of the trial
Study Population
100 HIV infected adults with chronic hepatitis C infection who have failed to achieve a sustained virologic response following previous interferon therapy
Dosage and Administration
Combo-therapy Peginterferon a-2a 180mg by subcutaneous route once weekly plus
Ribavirin
800 mg 400 mg bid if body weight 65 kg
1000 mg 400 mg am and 600 mg pm if body weight 65 kg and 85 kg
1200 mg 600 mg bid if body weight 85 kg Mono-therapy Peginterferon a-2a 90mg in 1mL solution administered subcutaneously once weekly
Efficacy Evaluations
Laboratory analysis liver biopsies quality of life assessments and changes in Peginterferona-2a 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None