Assessment of the Antiviral Effect of Atorvastatin on Hepatitis C Virus

Hepatitis C Clinical Trial

Official title:

Assessment of the Antiviral Effect of Atorvastatin on Hepatitis C Virus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00403533
• Other study ID #: 2006-P-000138/1
• Secondary ID: AASLD advanced h
• Status: Completed
• Phase: Phase 2
• First received: November 21, 2006
• Last updated: November 22, 2006
• Start date: February 2006
• Est. completion date: July 2006

Study information

• Verified date: November 2006
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with chronic HCV.

• Patients who need treatment for their elevated cholesterol:

• Total cholesterol >240 or

• LDL >160 without cardiac risk factors or

• LDL >130 with two cardiac risk factors (hypertension, smoker, family history of heart attach, or HDL <40 for men or <50 for women) or

• LDL >100 with diabetes or known coronary artery disease

Exclusion Criteria:

• Impaired mental ability preventing a subject from understanding the protocol or from completing the entire study.

• HCC

• A history of an adverse reaction to any HMG CoA reductase inhibitor.

• Patients who are on HCV treatment, who plan to initiate HCV treatment within 3 months, or who discontinued HCV treatment within the last 3 months.

• Patients whose aminotransferases are > 5 times the upper limit of normal.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• 20 mg of atorvastatin daily

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (3)

Aizaki H, Lee KJ, Sung VM, Ishiko H, Lai MM. Characterization of the hepatitis C virus RNA replication complex associated with lipid rafts. Virology. 2004 Jul 1;324(2):450-61. — View Citation

Ikeda M, Abe K, Yamada M, Dansako H, Naka K, Kato N. Different anti-HCV profiles of statins and their potential for combination therapy with interferon. Hepatology. 2006 Jul;44(1):117-25. — View Citation

Kapadia SB, Chisari FV. Hepatitis C virus RNA replication is regulated by host geranylgeranylation and fatty acids. Proc Natl Acad Sci U S A. 2005 Feb 15;102(7):2561-6. Epub 2005 Feb 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Paired comparison of pretreatment viral load to post-treatment 12 week viral load
Secondary	Paired comparison of pretreatment viral load to post-treatment 4 week viral load