Effect of Rosuvastatin on Endothelial Function

NCT ID: NCT00986999

Last Updated: 2015-01-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30

Brief Summary

Rosuvastatin belongs to a class of medications commonly called "statins" which are medications given for high low density lipoprotein (LDL) 'bad' cholesterol to prevent atherosclerosis (hardening of blood vessels) and lower risk of heart attacks and other circulation problems. Recent studies in the general non-HIV infected population have shown that the beneficial effect of statins in preventing circulation problems is larger than would be expected from lowering of LDL-cholesterol alone. It has been suggested that the additional beneficial effect of statins may be due to the anti-inflammatory effect of statins.

The risk of heart attacks and other circulation problems may be high in HIV infected individuals. This may be due to the inflammatory stress effects of HIV. The main purpose of the study is to see if rosuvastatin will have a beneficial effect on the circulatory system in HIV infected individuals even in those who do not have high LDL cholesterol levels. Therefore, in HIV-infected individuals with normal or low LDL cholesterol levels but with evidence of low HDL cholesterol levels which may be a sign of low grade inflammation, the study will look at whether 3 months of rosuvastatin will lead to improvement in brachial artery flow-mediated dilatation (FMD), a marker of early atherosclerosis (hardening of the blood vessels).

Conditions

HIV Infections; Cardiovascular Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

rosuvastatin

rosuvastatin 10 mg qd increased to 20 mg qd as tolerated

Group Type: EXPERIMENTAL

rosuvastatin

Intervention Type: DRUG

rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years

Interventions

rosuvastatin

rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years

Intervention Type: DRUG

Other Intervention Names

Crestor

Eligibility Criteria

Inclusion Criteria

• HIV infection
• Age > 18 years old
• On stable antiretroviral therapy for > 6 months with no plans to change therapy during the treatment phase of the study
• Plasma HIV RNA < 50 copies/mL
• Karnofsky performance score > 70 within 30 days prior to study entry
• Ability to understand and sign informed consent
• Following laboratory values obtained within 30 days prior to randomization:

• Absolute neutrophil count (ANC) > 750/mm3
• Hemoglobin >/= 8.0 g/dL
• Platelets >/= 50,000/mm3
• ALT (SGPT) and AST (SGOT) < 2.5 x ULN
• Fasting glucose < 126 mg/dL
• TSH < 3.0 mIU/L
• HDL-C < 50 mg/dL in men, < 55 mg/dL in women
• Direct LDL-C </= 130 mg/dL
• Calculated creatinine clearance > 50 mL/min
• Willing to be treated with rosuvastatin or be on an observational arm for a minimum of 3 months
• Female subject must not participate in a conception process (active attempt to become pregnant) or be post-menopausal. If participating in sexual activity that could lead to pregnancy, the subject must use contraception while receiving study medication and 30 days after stopping the medication

Exclusion Criteria

• History of past cardiovascular event
• Acute illnesses or active AIDS-defining opportunistic infection (OI) within 30 days prior to entry
• Other chronic illness including diabetes, autoimmune diseases, and endocrinopathies
• Serology positive for hepatitis B surface antigen or hepatitis C antibody
• Signs and symptoms of liver failure
• Receipt of supraphysiologic glucocorticoid therapy within 3 months prior to study entry
• Use of lipid lowering agents within 30 days prior to study entry
• Receipt of an HIV vaccine or investigational agents
• Pregnancy or breast-feeding
• Presence of any active malignancy within the last 5 years
• Severe Hypertension (Systolic >/= 180 or Diastolic >/= 110 mm Hg)
• Use of oral postmenopausal hormone replacement therapy
• Known hypersensitivity to rosuvastatin
• Active drug or alcohol dependence
• Any acute illness within 30 days prior to study entry that, in the opinion of the site investigator, would interfere with participation in the study.
• Use of lopinavir/ritonavir (Kaletra) as part of current HIV antiretroviral regimen

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Hawaii

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cecilia Shikuma, MD

Role: PRINCIPAL_INVESTIGATOR

Hawaii Center for AIDS, John A. Burns School of Medicine, University of Hawaii

Locations

Hawaii Center for AIDS

Honolulu, Hawaii, United States

Countries

United States

Other Identifiers

R01HL095135

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H002

Identifier Type: -

Identifier Source: org_study_id