Document Detail

Inflammatory biomarker changes and their correlation with Framingham cardiovascular risk and lipid changes in antiretroviral-naive HIV-infected patients treated for 144 weeks with abacavir/lamivudine/atazanavir with or without ritonavir in ARIES.
MedLine Citation:
PMID:  23039030     Owner:  NLM     Status:  MEDLINE    
Propensity for developing coronary heart disease (CHD) is linked with Framingham-defined cardiovascular risk factors and elevated inflammatory biomarkers. Cardiovascular risk and inflammatory biomarkers were evaluated in ARIES, a Phase IIIb/IV clinical trial in which 515 antiretroviral-naive HIV-infected subjects initially received abacavir/lamivudine + atazanavir/ritonavir for 36 weeks. Subjects who were virologically suppressed by week 30 were randomized 1:1 at week 36 to either maintain or discontinue ritonavir for an additional 108 weeks. Framingham 10-year CHD risk scores (FRS) and risk category of <6% or ≥6%, lipoprotein-associated phospholipase A(2) (Lp-PLA(2)), interleukin-6 (IL-6), and high-sensitivity C-reactive protein (hsCRP) were assessed at baseline, week 84, and week 144. Biomarkers were stratified by FRS category. When ritonavir-boosted/nonboosted treatment groups were combined, median hsCRP did not change significantly between baseline (1.6 mg/liter) and week 144 (1.4 mg/liter) in subjects with FRS <6% (p=0.535) or with FRS ≥6% (1.9 mg/liter vs. 2.0 mg/liter, respectively; p=0.102). Median IL-6 was similar for subjects with FRS <6% (p=0.267) at baseline (1.6 pg/ml) and week 144 (1.4 pg/ml) and for FRS ≥6% (2.0 pg/ml vs. 2.2 pg/ml, respectively; p=0.099). Median Lp-PLA(2) decreased significantly (p<0.001) between baseline (197 nmol/min/ml) and week 144 (168 nmol/min/ml) in subjects with FRS <6% and with FRS ≥6% (238 nmol/min/ml vs. 175 nmol/min/ml, respectively; p<0.001). In conclusion, in antiretroviral-naive subjects treated with abacavir-based therapy for 144 weeks, median inflammatory biomarker levels for hsCRP and IL-6 generally remained stable with no significant difference between baseline and week 144 for subjects with either FRS <6% or FRS ≥6%. Lp-PLA(2) median values declined significantly over 144 weeks for subjects in either FRS stratum.
Benjamin Young; Kathleen E Squires; Lisa L Ross; Lizette Santiago; Louis M Sloan; Henry H Zhao; Brian C Wine; Gary E Pakes; David A Margolis; Mark S Shaefer;
Publication Detail:
Type:  Clinical Trial, Phase III; Clinical Trial, Phase IV; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2012-12-05
Journal Detail:
Title:  AIDS research and human retroviruses     Volume:  29     ISSN:  1931-8405     ISO Abbreviation:  AIDS Res. Hum. Retroviruses     Publication Date:  2013 Feb 
Date Detail:
Created Date:  2013-01-22     Completed Date:  2013-07-01     Revised Date:  2013-07-12    
Medline Journal Info:
Nlm Unique ID:  8709376     Medline TA:  AIDS Res Hum Retroviruses     Country:  United States    
Other Details:
Languages:  eng     Pagination:  350-8     Citation Subset:  IM; X    
Apex Family Medicine and Research, Denver, Colorado 80209, USA.
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MeSH Terms
1-Alkyl-2-acetylglycerophosphocholine Esterase / blood
Anti-HIV Agents / administration & dosage
Biological Markers / blood
C-Reactive Protein / analysis
Coronary Disease / epidemiology*
Dideoxynucleosides / administration & dosage*
Drug Combinations
HIV Infections / drug therapy*,  pathology
Inflammation / pathology*
Interleukin-6 / blood
Lamivudine / administration & dosage*
Lipids / blood*
Longitudinal Studies
Middle Aged
Oligopeptides / administration & dosage*
Pyridines / administration & dosage*
Risk Assessment
Ritonavir / administration & dosage*
Treatment Outcome
Young Adult
Reg. No./Substance:
0/Anti-HIV Agents; 0/Biological Markers; 0/Dideoxynucleosides; 0/Drug Combinations; 0/Interleukin-6; 0/Lipids; 0/Oligopeptides; 0/Pyridines; 0/Ritonavir; 0/abacavir, lamivudine drug combination; 134678-17-4/Lamivudine; 9007-41-4/C-Reactive Protein; EC Esterase; QZU4H47A3S/atazanavir

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