Atherosclerosis, Cardiovascular Risk Factor, HIV Infection With Other Conditions, Inflammation
Conditions
Keywords
HIV, Maraviroc, Atherosclerosis
Brief summary
The investigator tested the efficacy of maraviroc intensification on down-regulating atherosclerotic progression in HIV infected patients with optimal viro-immunologic control and at high cardiovascular risk.
Detailed description
Experimental CCR5 antagonism with maraviroc in atherosclerosis-prone mice and preliminary data in humans suggest an anti-atherosclerotic effect of the drug. The investigators assessed the impact of maraviroc treatment in HIV-infected patients on several subclinical indicators of atherosclerosis and putative mechanisms for such an effect. HIV-treated patients under effective antiretroviral (ART) therapy, with a Framingham risk score \>20% and a brachial flow-mediated dilation (bFMD) \<4%, as indices of high cardiovascular risk, were recruited. Maraviroc (300 mg per os for 24 weeks) was administered on top of ART to all participants using a cross-over design. Brachial FMD, carotid-femoral pulse wave velocity (cfPWV) and carotid intima-media thickness (cIMT) were measured as non-invasive markers of atherosclerosis. Vascular competence, as expressed by the ratio of circulating endothelial micro-particles (EMPs) to endothelial progenitor cells (EPCs), as well as markers of systemic inflammation, monocyte activation and platelet activation were assessed.
Interventions
DRUGMaraviroc 300 mg
Patients were randomly allocated with an AB/BA cross over design to either maraviroc 300 mg/day to current ART for 24 weeks (A) or no additional treatment (B). At the end of the first 24-week period patients were switched to the alternative arm.
Sponsors
University Of Perugia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Eligible patients were consecutive ≥50-year-old individuals, treated for over 1 year with an effective protease inhibitor ART regimen (HIV RNA \<50 copies/mL), with CD4 T cell counts \> 300/ mm3 for at least 6 months and a Framingham risk score \>20% and bFMD \<4%.
Exclusion criteria
* Patients over 70 years of age, with life expectancy \< 12 months, with known platelets functional defects or alcohol chronic abuse were excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change Flow Mediated Dilation | 24 weeks |
| Change in Intima-Media Thickness | 24 weeks |
| Change in carotid-femoral Pulse Wave Velocity | 24 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in inflammatory markers | 24 weeks | change in CRP, IL6, D-dimer |
| Endothelial microparticles/endothelial progenitor cells ratio | 24 weeks | — |
Countries
Italy
Outcome results
None listed