Ignite Creation Date:
2024-05-06 @ 2:47 AM
Last Modification Date:
2024-10-26 @ 11:23 AM
Study NCT ID:
NCT02124044
Status:
COMPLETED
Last Update Posted:
2017-05-16
First Post:
2014-04-25
Brief Title:
Safety Tolerability and Efficacy of Asunaprevir and Daclatasvir in Subjects Coinfected With HIV-HCV
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Safety Tolerability and Efficacy of Daclatasvir and Asunaprevir With or Without BMS-791325 in Subjects Coinfected With HIV-HCV
Status:
COMPLETED
Status Verified Date:
2017-04
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:
Chronic hepatitis C virus HCV infection is a major public health problem with an estimated 180 million people infected worldwide In the United States an estimated 41 million people are infected and HCV is the principal cause of death from liver disease and leading indication for liver transplantation Within HIVHCV co-infected patients liver disease due to Hepatitis C progresses even more rapidly While combination of ribavirin RBV and pegylated interferon PEG in combination with boceprevirtelaprevir is the currently recommended therapy for chronic HCV infection and has superior cure rates compared to PEGRBV alone in HCV monoinfected patients treatment is still associated with a high incidence of adverse events AEs discontinuations and poor cure rates in several populations Within the HIVHCV co-infected population treatment for HCV remains complicated given drug interactions between anti-retrovirals and HCV protease inhibitors in addition to the extensive side-effects due to PEG RBV alone Recent studies have demonstrated that the use of a combination of anti-virals which target HCV without interferon IFN can cure HCV without additional toxicities These novel therapies that do not rely on an IFN backbone may additionally enhance cure rates in HIVHCV co-infected a population which has historically been difficult to cure
The findings from this study will aid in the understanding of antiviral and host responses and determinants of response to an IFN free regimen in HIVHCV co-infected patients
The findings from this study will aid in the understanding of antiviral and host responses and determinants of response to an IFN free regimen in HIVHCV co-infected patients
Detailed Description:
Chronic hepatitis C virus HCV infection is a major public health problem with an estimated 180 million people infected worldwide In the United States an estimated 41 million people are infected and HCV is the principal cause of death from liver disease and leading indication for liver transplantation Within HIVHCV co-infected patients liver disease due to Hepatitis C progresses even more rapidly While combination of ribavirin RBV and pegylated interferon PEG in combination with boceprevirtelaprevir is the currently recommended therapy for chronic HCV infection and has superior cure rates compared to PEGRBV alone in HCV monoinfected patients treatment is still associated with a high incidence of adverse events AEs discontinuations and poor cure rates in several populations Within the HIVHCV co-infected population treatment for HCV remains complicated given drug interactions between anti-retrovirals and HCV protease inhibitors in addition to the extensive side-effects due to PEG RBV alone Recent studies have demonstrated that the use of a combination of anti-virals which target HCV without interferon IFN can cure HCV without additional toxicities These novel therapies that do not rely on an IFN backbone may additionally enhance cure rates in HIVHCV co-infected a population which has historically been difficult to cure
This is an open label study to assess the safety tolerability and efficacy of two regimens for the treatment of HCV asunaprevir ASV 100 mg BID and daclatasvir DCV 60 mg daily selective HCV NS3 and NS5A inhibitors respectively in 10 HIVHCV genotype 1b co-infected treatment-naive and treatment experienced individuals and DCV ASV BMS-791325 administered as a fixed dose combination FDC pill in 20 HIVHCV GT 1a or 1b coinfected treatment-naive and treatment experienced individuals
The findings from this study will aid in the understanding of antiviral and host responses and determinants of response to an IFN free regimen in HIVHCV co-infected patients
This is an open label study to assess the safety tolerability and efficacy of two regimens for the treatment of HCV asunaprevir ASV 100 mg BID and daclatasvir DCV 60 mg daily selective HCV NS3 and NS5A inhibitors respectively in 10 HIVHCV genotype 1b co-infected treatment-naive and treatment experienced individuals and DCV ASV BMS-791325 administered as a fixed dose combination FDC pill in 20 HIVHCV GT 1a or 1b coinfected treatment-naive and treatment experienced individuals
The findings from this study will aid in the understanding of antiviral and host responses and determinants of response to an IFN free regimen in HIVHCV co-infected patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 14-CC-0065 | OTHER | National Institutes of Health | None |