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Completed

NCT Number: NCT00403533

Assessment of the Antiviral Effect of Atorvastatin on Hepatitis C Virus

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.

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Key information

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

20 mg of atorvastatin daily

Drug

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2006
Study completion
2006
First posted
Nov 23, 2006
Registry last updated
Nov 23, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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