Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00403533
Status:
COMPLETED
Last Update Posted:
2006-11-23
First Post:
2006-11-21
Brief Title:
Assessment of the Antiviral Effect of Atorvastatin on Hepatitis C Virus
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Assessment of the Antiviral Effect of Atorvastatin on Hepatitis C Virus
Status:
COMPLETED
Status Verified Date:
2006-11
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:
We hypothesize that atorvastatin will decrease HCV viral load in patients taking the medication
Cholesterol is needed for HCV virion production Cell culture studies have shown that atorvastatin an HMG-CoA reductase inhibitor decreases HCV viral replication As atorvastatin has been proven to decrease heart attack and stroke in patients with high cholesterol this medication is indicated for the treatment of elevated cholesterol in at risk individuals Therefore we propose to study the effect atorvastatin has on the viral load of patients initiated on atorvastatin therapy for their elevated cholesterol
Cholesterol is needed for HCV virion production Cell culture studies have shown that atorvastatin an HMG-CoA reductase inhibitor decreases HCV viral replication As atorvastatin has been proven to decrease heart attack and stroke in patients with high cholesterol this medication is indicated for the treatment of elevated cholesterol in at risk individuals Therefore we propose to study the effect atorvastatin has on the viral load of patients initiated on atorvastatin therapy for their elevated cholesterol
Detailed Description:
Men and women ages 30 to 80 infected with HCV viremia whose physician has determined need cholesterol lowering medication will be recruited by the study investigators from Massachusetts General Hospital
The study investigators will approach the potential subject after the referring doctor has ascertained that the potential subject is interested in meeting with the investigator
Each subject who consents will undergo phlebotomy of 10 cc of blood three times Once prior to the initiation of atorvastatin to measure the patients viral load In addition patients will undergo phlebotomy 4 and 12 weeks after the initiation of atorvastatin The week 12 phlebotomy is required in all patients started on atorvastatin to monitor for side effects Therefore patients who enroll in this study will undergo one additional phlebotomy As part of our study an extra 10 cc of blood will be taken at these times to measure the patients HCV viral load
The study investigators will approach the potential subject after the referring doctor has ascertained that the potential subject is interested in meeting with the investigator
Each subject who consents will undergo phlebotomy of 10 cc of blood three times Once prior to the initiation of atorvastatin to measure the patients viral load In addition patients will undergo phlebotomy 4 and 12 weeks after the initiation of atorvastatin The week 12 phlebotomy is required in all patients started on atorvastatin to monitor for side effects Therefore patients who enroll in this study will undergo one additional phlebotomy As part of our study an extra 10 cc of blood will be taken at these times to measure the patients HCV viral load
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 |
|---|---|---|---|
| AASLD advanced hepato grant | None | None | None |