Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00353418
Status:
COMPLETED
Last Update Posted:
2010-08-03
First Post:
2006-07-17
Brief Title:
A Study of PEGASYS Peginterferon Alfa-2a 40KD Plus COPEGUS Ribavirin in Patients With Chronic Hepatitis C CHC Genotype 1 and Human Immunodeficiency Virus-1 HIV-1 Co-infection
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Randomized Multicenter Double Blinded Study Comparing the Safety and Efficacy of Pegasys 180 ug Plus Copegus 1000 or 1200 mg to the Currently Approved Combination of Pegasys 180 ug Plus Copegus 800 mg in Interferon-naïve Patients With Chronic Hepatitis C Genotype 1 Virus Infection and HIV-1
Status:
COMPLETED
Status Verified Date:
2010-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This 2-arm study will compare the efficacy and safety of treatment with Pegasys 180 µg weekly plus Copegus 800 mg daily and Pegasys 180 µg weekly plus Copegus 1000-1200 mg daily in interferon-naive patients with CHC genotype 1 co-infected with HIV-1 Treatment will be administered for 48 weeks and this will be followed by 24 treatment-free weeks The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals
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