PMID- 19436663
OWN - NLM
STAT- MEDLINE
DCOM- 20090619
LR  - 20220309
IS  - 1178-2048 (Electronic)
IS  - 1176-6344 (Print)
IS  - 1176-6344 (Linking)
VI  - 5
IP  - 1
DP  - 2009
TI  - Prevention of atherosclerosis in patients living with HIV.
PG  - 287-300
AB  - INVESTIGATIONAL PRODUCT: Rosuvastatin (Crestor; Astra Zeneca). ACTIVE 
      INGREDIENTS: Rosuvastatin (5 mg). STUDY TITLE: Prevention of Atherosclerosis in 
      Patients Living with HIV. PHASE OF STUDY: Phase III. AIMS: PRIMARY AIM: To assess 
      whether rosuvastatin therapy could slow the progression of the carotid 
      intima-media thickness (C-IMT; as measured by the change in the mean IMT of the 
      near and far walls of the distal common carotid arteries) over 2 years in 
      HIV-infected patients (HIV-IP). SECONDARY AIMS: To assess whether rosuvastatin 
      therapy could reduce highly sensitive C reactive protein (hs-CRP) inflammatory 
      marker that is increased in HIV-IP.To assess the effect of rosuvastatin therapy 
      on serum lipid levels (total cholesterol [TC], low-density lipoprotein [LDL] 
      cholesterol, high-density lipoprotein [HDL] cholesterol and triglycerides [TG]) 
      and apolipoproteins (APO A1, APO B and APO B/A1).To assess the safety of 
      rosuvastatin in HIV-IP through the evaluation of clinical laboratory analyses 
      (liver function tests and creatine kinase) and adverse events (AEs). STUDY 
      DESIGN: Two-year randomized, double-blind, placebo-controlled, parallel group 
      study. PLANNED SAMPLE SIZE: 320 HIV-IP. SUMMARY OF ELIGIBILITY CRITERIA: HIV-IP 
      who are aged between 30 and 60 years, with a CD4 count. greater than 200 
      cells/mm(3). Patients must be stable on combination antiretroviral therapy (cART) 
      for at least 12 months and have a 10-year CVD risk of less than 20% (using the 
      Framingham risk score). NUMBER OF STUDY CENTERS: One. DURATION OF TREATMENT: Two 
      years (5 mg rosuvastatin or placebo once daily). DOSE AND ROUTE OF 
      ADMINISTRATION: Oral rosuvastatin (5 mg) once daily. The incidence of 
      cardiovascular disease (CVD) in HIV-IP is at least three times higher than in the 
      general population and further increases each year with combination 
      anti-retroviral therapy (cART). The carotid atherosclerosis progression rate is 
      10 times higher in HIV-IP than in uninfected individuals. The aim of this study 
      is to assess whether therapy with 5 mg rosuvastatin could: 1) Slow the 
      progression in the mean IMT of the distal common carotid arteries over two years 
      in HIV-IP.2) Change the concentration in the inflammatory marker--hs-CRP, which 
      is increased in HIV-IP.3) Change the concentrations of TC, LDL cholesterol, HDL 
      cholesterol, TG, apolipoproteins (APO) B, APO A1 and APO B/A1.4) Be administered 
      safely in the study population. Pharmacological intervention with rosuvastatin 
      will be evaluated in a double-blind, placebo-controlled, randomized clinical 
      trial in HIV-IP treated with cART not matching the published selection criteria 
      for lipid-lowering therapy. For the first time, this study will investigate 
      anti-inflammatory and anti-atherogenic effects of a pharmacological 
      lipid-lowering agent in HIV-IP that may lead to the reduction of CVD.
FAU - De Lorenzo, Ferruccio
AU  - De Lorenzo F
AD  - General Medicine and Prevention of Vascular Disorders, Beta Cell Diabetes Centre 
      and St Stephen's AIDS Trust, Chelsea and Westminster Hospital NHS Foundation 
      Trust, London, UK. fdlx@btinternet.com
FAU - Boffito, Marta
AU  - Boffito M
FAU - Collot-Teixeira, Sophie
AU  - Collot-Teixeira S
FAU - Gazzard, Brian
AU  - Gazzard B
FAU - McGregor, John L
AU  - McGregor JL
FAU - Shotliff, Kevin
AU  - Shotliff K
FAU - Xiao, Han
AU  - Xiao H
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20090408
PL  - New Zealand
TA  - Vasc Health Risk Manag
JT  - Vascular health and risk management
JID - 101273479
RN  - 0 (Biomarkers)
RN  - 0 (Fluorobenzenes)
RN  - 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors)
RN  - 0 (Lipids)
RN  - 0 (Pyrimidines)
RN  - 0 (Sulfonamides)
RN  - 83MVU38M7Q (Rosuvastatin Calcium)
RN  - 9007-41-4 (C-Reactive Protein)
SB  - IM
MH  - Administration, Oral
MH  - Adult
MH  - Antiretroviral Therapy, Highly Active
MH  - Atherosclerosis/blood/pathology/*prevention & control/virology
MH  - Biomarkers/blood
MH  - C-Reactive Protein/metabolism
MH  - Carotid Artery Diseases/blood/pathology/*prevention & control/virology
MH  - Disease Progression
MH  - Double-Blind Method
MH  - Fluorobenzenes/administration & dosage/adverse effects/*therapeutic use
MH  - HIV Infections/complications/*drug therapy/virology
MH  - Humans
MH  - Hydroxymethylglutaryl-CoA Reductase Inhibitors/administration & dosage/adverse 
      effects/*therapeutic use
MH  - Lipids/blood
MH  - Middle Aged
MH  - Pyrimidines/administration & dosage/adverse effects/*therapeutic use
MH  - Research Design
MH  - Rosuvastatin Calcium
MH  - Sulfonamides/administration & dosage/adverse effects/*therapeutic use
MH  - Time Factors
MH  - Treatment Outcome
PMC - PMC2672452
OTO - NOTNLM
OT  - HIV
OT  - atherosclerosis
OT  - cardiovascular disease
OT  - clinical trial protocol
OT  - rosuvastatin
EDAT- 2009/05/14 09:00
MHDA- 2009/06/20 09:00
PMCR- 2009/08/08
CRDT- 2009/05/14 09:00
PHST- 2009/05/14 09:00 [entrez]
PHST- 2009/05/14 09:00 [pubmed]
PHST- 2009/06/20 09:00 [medline]
PHST- 2009/08/08 00:00 [pmc-release]
AID - vhrm-5-287 [pii]
AID - 10.2147/vhrm.s5206 [doi]
PST - ppublish
SO  - Vasc Health Risk Manag. 2009;5(1):287-300. doi: 10.2147/vhrm.s5206. Epub 2009 Apr 
      8.