Effect of Rosuvastatin on Endothelial Function

NCT00986999 | Terminated Phase 2 Results

• 2 other identifiers: H002R01HL095135
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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

Keywords

HIV infected; treatment experienced

Outcome Measures

Primary Outcomes (1)

• Change in Flow Mediated Dilatation (FMD) of the Brachial Artery

  3 months

Secondary Outcomes (5)

• Change in HIV Biomarkers of Immune Activation to Include CD38 and CD69 Expression on T Cells and CD16 and CD69 Expression on Monocytes

  3 months

• Change in Mitochondrial-specific Oxidative Stress (Mt-specific 8-oxo-dG) and Oxidative Phosphorylation (OXPHOS) Protein/Enzyme Activity [Complex I and Complex IV] Levels

  3 months

• Change in Glucose Homeostasis and Insulin Resistance as Assessed by Oral Glucose Tolerance Testing

  3 months

• Change in Total, HDL and LDL Cholesterol and Triglyceride Levels

  3 months

• Change in hsCRP

  3 months

Study Arms (1)

rosuvastatin

EXPERIMENTAL

rosuvastatin 10 mg qd increased to 20 mg qd as tolerated

Drug: rosuvastatin

Interventions

rosuvastatin 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

Also known as: Crestor

rosuvastatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Hawaii: lead

Study Sites (1)

Hawaii Center for AIDS

Honolulu, Hawaii, 96813, United States

Location

MeSH Terms

Conditions

HIV Infections; Cardiovascular Diseases

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Cecilia M. Shikuma M.D.
• Organization: University of Hawaii

shikuma@hawaii.edu

808 692-1328

Study Officials

• Cecilia Shikuma, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2009
• First Posted: September 30, 2009
• Study Start: September 1, 2009
• Primary Completion: January 1, 2015
• Last Updated: January 29, 2015
• Results First Posted: January 29, 2015

Record last verified: 2015-01

Locations

US (1)