Assessment of the Antiviral Effect of Atorvastatin on Hepatitis C Virus - Full Text View

Sponsor:	Massachusetts General Hospital
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00403533

Purpose

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	Intervention	Phase
Hepatitis C	Drug: 20 mg of atorvastatin daily	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Control: Uncontrolled Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Assessment of the Antiviral Effect of Atorvastatin on Hepatitis C Virus

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Hepatitis Hepatitis C

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Paired comparison of pretreatment viral load to post-treatment 12 week viral load

Secondary Outcome Measures:

Paired comparison of pretreatment viral load to post-treatment 4 week viral load

Estimated Enrollment:	10
Study Start Date:	February 2006
Estimated Study Completion Date:	July 2006

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.

Eligibility

Ages Eligible for Study:	30 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403533

Locations

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

Principal Investigator:

Raymond T Chung, MD

Massachusetts General Hospital

More Information

Publications:

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.

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.

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.

Study ID Numbers:	2006-P-000138/1, AASLD advanced hepato. grant
Study First Received:	November 21, 2006
Last Updated:	November 22, 2006
ClinicalTrials.gov Identifier:	NCT00403533 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

Hepatitis C
viral load
antiviral therapy
cholesterol
atorvastatin

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Liver Diseases
RNA Virus Infections
Molecular Mechanisms of Pharmacological Action
Flaviviridae Infections
Antilipemic Agents
Hepatitis, Viral, Human
Enzyme Inhibitors
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Antiviral Agents
Pharmacologic Actions
Hepatitis
Virus Diseases
Digestive System Diseases
Therapeutic Uses
Hepatitis C
Atorvastatin

ClinicalTrials.gov processed this record on March 18, 2010