Assessment of the Antiviral Effect of Atorvastatin on Hepatitis C Virus
|ClinicalTrials.gov Identifier: NCT00403533|
Recruitment Status : Completed
First Posted : November 23, 2006
Last Update Posted : November 23, 2006
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.
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C||Drug: 20 mg of atorvastatin daily||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessment of the Antiviral Effect of Atorvastatin on Hepatitis C Virus|
|Study Start Date :||February 2006|
|Estimated Study Completion Date :||July 2006|
- Paired comparison of pretreatment viral load to post-treatment 12 week viral load
- Paired comparison of pretreatment viral load to post-treatment 4 week viral load
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00403533
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Raymond T Chung, MD||Massachusetts General Hospital|