Ignite Creation Date:
2024-05-05 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00526448
Status:
UNKNOWN
Last Update Posted:
2009-01-29
First Post:
2007-09-05
Brief Title:
Phase IV Study to Evaluate the EfficacySafety to Extend Treatment and High Dose of Ribavirin in co-Infected Patients
Sponsor:
Hospital Carlos III Madrid
Organization:
Hospital Carlos III Madrid
Study Overview
Official Title:
Open MulticentreRandomized Phase IV Trial to Evaluate EfficacySafety to Extend Treatment Duration With Peginterferon Alfa-2aHigh Dose of Ribavirin Supporting Epo β in Treatment of CHC in HIV-HCV Patients Who Not Clear Virus at Week 4
Status:
UNKNOWN
Status Verified Date:
2009-01
Last Known Status:
RECRUITING
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:
PERICO
Brief Summary:
To compare the sustained virological response SVR ribonucleic acid RNA - hepatitis C virus HCV undetectable at week 24 before end the treatment in chronic hepatitis C patients genotype 1-4 co-infected with HIV-HCV treated with Peginterferón alfa-2a 40 KD 180 µgweek and Ribavirin 2000 mgday during 4 weeks follow of 1000-1200 mgday according to body weight versus Peginterferón alfa-2a 40 KD 180 μgweek and Ribavirin 1000-1200 mgday according to body weight
To evaluate the impact to extend the treatment with Peginterferon alfa-2a and Ribavirin to week 72 in SVR of these patients with genotypes 1-4 without rapid virological response RVR RNA - HCV undetectable at 4 week
To evaluate the impact to extend the treatment with Peginterferon alfa-2a and Ribavirin to week 72 in SVR of these patients with genotypes 1-4 without rapid virological response RVR RNA - HCV undetectable at 4 week
Detailed Description:
The PRESCO study ribavirin dose 1000-1200 mgday emphasized that optimal ribavirin exposure seems to be crucial to maximize sustained virological response and minimize the incidence of relapses after treatment discontinuations
Recent reports showed that it is beneficial to extend the treatment duration in patients without rapid virological response at 4 weeks RNA-HCV 50 UIml
Recent reports showed that it is beneficial to extend the treatment duration in patients without rapid virological response at 4 weeks RNA-HCV 50 UIml
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