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AIDS. 2015 Sep 10;29(14):1775-83. doi: 10.1097/QAD.0000000000000762.

A prospective, randomized clinical trial of antiretroviral therapies on carotid wall thickness.

Author information

1
aUniversity of Wisconsin School of Medicine and Public Health, Madison, Wisconsin bHarvard School of Public Health, Boston, Massachusetts cKeck School of Medicine, University of Southern California, Los Angeles, California dJohns Hopkins University School of Medicine, Baltimore, Maryland eCase School of Medicine, Cleveland, Ohio fFeinberg School of Medicine, Northwestern University, Chicago, Illinois gDavid Geffen School of Medicine, University of California-Los Angeles, Los Angeles, California, USA.

Erratum in

  • AIDS. 2016 Jan;30(2):337.

Abstract

OBJECTIVE:

This article compares the effects of initiating three contemporary antiretroviral therapy (ART) regimens on progression of carotid artery intima-media thickness (IMT) over 3 years.

DESIGN:

Randomized clinical trial.

SETTING:

Multicenter (26 institutions).

PATIENTS:

ART-naive HIV-infected individuals (n = 328) without known cardiovascular disease or diabetes mellitus.

INTERVENTION:

Random assignment to tenofovir/emtricitabine along with atazanavir/ritonavir (ATV/r), darunavir/ritonavir (DRV/r), or raltegravir (RAL).

MAIN OUTCOME MEASURES:

Right-sided carotid IMT was evaluated by B-mode ultrasonography before ART initiation, and then after 48, 96, and 144 weeks. Comparisons of yearly rates of change in carotid IMT used mixed-effects linear regression models that permitted not only evaluation of the effects of ART on carotid IMT progression but also how ART-associated changes in traditional risk factors, bilirubin, and markers of HIV infection were associated carotid IMT progression.

RESULTS:

HIV-1 RNA suppression rates were high in all arms (>85%) over 144 weeks. Modest increases in triglycerides and non-high-density lipoprotein cholesterol levels were observed in the protease inhibitor-containing arms compared with decreases with RAL. In contrast, carotid IMT progressed more slowly on ATV/r [8.2, 95% confidence interval (5.6, 10.8) μm/year] than DRV/r [12.9 (10.3, 15.5) μm/year, P = 0.013]; changes with RAL were intermediate [10.7 (9.2, 12.2) μm/year, P = 0.15 vs. ATV/r; P = 0.31 vs. DRV/r]. Bilirubin and non-high-density lipoprotein cholesterol levels appeared to influence carotid IMT progression rates.

CONCLUSION:

In ART-naive HIV-infected individuals at low cardiovascular disease risk, carotid IMT progressed more slowly in participants initiating ATV/r than those initiating DRV/r, with intermediate changes associated with RAL. This effect may be due, in part, to hyperbilirubinemia.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00851799.

PMID:
26372383
PMCID:
PMC4571277
DOI:
10.1097/QAD.0000000000000762
[Indexed for MEDLINE]
Free PMC Article

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