Ignite Creation Date:
2024-05-06 @ 1:55 AM
Last Modification Date:
2024-10-26 @ 11:11 AM
Study NCT ID:
NCT01925183
Status:
COMPLETED
Last Update Posted:
2017-03-16
First Post:
2013-08-15
Brief Title:
Individualized Triple-therapy Using Boceprevir in HIV-positive Patients With Hepatitis C
Sponsor:
Markus Peck-Radosavljevic
Organization:
Medical University of Vienna
Study Overview
Official Title:
Response-guided Triple-therapy Using Boceprevir in Combination With PEGIFNRBV in HIVHCV-coinfected Patients
Status:
COMPLETED
Status Verified Date:
2017-02
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:
HIVCOBOC-RGT
Brief Summary:
Response-guided triple-therapy with boceprevir BOC in combination with pegylated interferon PEGIFN and ribavirin RBV is the current standard of care for HIV-negative patients infected with hepatitis C genotype HCV-GT 1 In contrast in HIV-positive patients a fixed treatment duration of 48 weeks is used
The aim of this study is to assess efficacy and safety of response-guided triple-therapy with BOC in combination with PEGIFN and RBV in HIV-positive patients Thus treatment duration will be individualized based on HCV-RNA negativity at treatment week 8 W8 All patients will receive 4 weeks of PEGIFNRBV lead-in Patients with undetectable HCV-RNA at W8 will be treated with 24 weeks of BOCPEGIFNRBV triple-therapy resulting in a total treatment duration of 28 weeks while patients with detectable HCV-RNA at W8 will receive 44 weeks of BOCPEGIFNRBV triple-therapy and a total treatment duration of 48 weeks
The aim of this study is to assess efficacy and safety of response-guided triple-therapy with BOC in combination with PEGIFN and RBV in HIV-positive patients Thus treatment duration will be individualized based on HCV-RNA negativity at treatment week 8 W8 All patients will receive 4 weeks of PEGIFNRBV lead-in Patients with undetectable HCV-RNA at W8 will be treated with 24 weeks of BOCPEGIFNRBV triple-therapy resulting in a total treatment duration of 28 weeks while patients with detectable HCV-RNA at W8 will receive 44 weeks of BOCPEGIFNRBV triple-therapy and a total treatment duration of 48 weeks
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2012-005591-33 | EUDRACT_NUMBER | None | None |