Table 1.
Randomized clinical trials of statins to improve vascular measures and clinical CVD outcomes in HIV-infected adults on ART
| (A) Completed | ||||||||
|---|---|---|---|---|---|---|---|---|
|
Clinicaltrials.gov Identifier |
Year Completed |
Population** | N | Intervention | Duration | Surrogate CVD outcome |
Main Results | References |
| N/A | 2004 | On stable PI; total cholesterol >3.36mmol/L and either triglycerides >3.88mmol/L or HDL <1.07mmol/L | 20 | Pravastatin 40mg vs. Placebo | 8 weeks | FMD | Trend toward improved FMD with pravastatin (p=0.08) | Stein et al.[17] |
| N/A | 2006 | On stable PI; total cholesterol >5mmol/L (193mg/dL) | 29 | Pravastatin 40mg vs. Placebo | 8 weeks | FMD | Improved FMD in statin arm vs. no change in placebo. | Hurlimann et al.[18] |
| NCT00227500 | 2006 | Men >18yrs; Stable PI; Total cholesterol >6.5mmol/L (251mg/dL) | 33 | Pravastatin 40mg vs. Placebo | 12 weeks | FMD | No difference in FMD change | Mallon et al.[19] |
| NCT00965185 | 2014 | Stable ART; subclinical coronary athero by CTA AND aortic inflammation by PET; LDL 70–130mg/dL | 40 | Atorvastatin (20–40mg) vs. Placebo | 12 months | Coronary CTA plaque features; Aortic TBR* | Reduced non-calcified plaque volume and # of high risk plaques; no difference in aortic TBR change | Lo et al.[20] |
| NCT01218802 | 2014 | Stable ART; LDL <130mg/dL; hsCRP >2 or elevated CD 8+ T-cell activation | 147 | Rosuvastatin 10mg vs. Placebo | 96 weeks | CIMT; FMD; CAC | Reduced 48 and 96 week CIMT progression; no difference in CAC change | Longenecker et al.[21] |
| (B) Ongoing | ||||||
|---|---|---|---|---|---|---|
|
Clinicaltrials.gov Identifier |
Estimated Completion |
Population | N | Intervention | Duration | CVD outcome(s) |
| NCT01881971 | 2016 | Stable ART; COPD | 30 | Rosuvastatin vs. Placebo | 24 months | CIMT; FMD |
| NCT02081638 | 2017 | Elite Controller or ART >4 yrs | 80† | Open label Aspirin 81mg vs. Atorvastatin 40mg | 9 months | Carotid MRI |
| NCT01813357 | 2017 | Stable ART; FRS 10–15% | 102 | Rosuvastatin 20mg vs. Placebo | 24 months | CIMT; FMD |
| NCT02234492 | 2018 | >40yrs; ART >2 yrs; FRS 10–20%; LDL <4mmol/L (<155mg/dL); | 82 | Open label Rosuvastatin 10mg vs. usual medical care | 6 months | Coronary Flow Reserve‡; Vascular TBR* |
| NCT02344290 | 2020 | 40–75yrs; stable ART; <7.5% 10yr risk | 6500 | Pitavastatin 4mg vs. Placebo | 42–72 months | MACE; Coronary CTA substudy |
Measured using 18-fluorodeoxyglucose positron emission tomography (18-FDG PET/CT)
Population includes most important inclusion/exclusion criteria; full criteria available at clinicaltrials.gov or in the published manuscript
40 elite controllers; 40 treated progressors
Measured using myocardial contrast echocardiography
PI, protease inhibitor; CTA, computed tomography angiography; TBR, Target to background ratio; CIMT, carotid intima-media thickness; FMD, flow-mediated dilation of the brachial artery; CAC, coronary artery calcium; COPD, chronic obstructive pulmonary disease; FRS, Framingham Risk Score; MACE, major adverse cardiovascular events (CVD death, nonfatal myocardial infarction, unstable angina hospitalization, coronary or peripheral arterial revascularization, nonfatal stroke or transient ischemic attack, urgent peripheral arterial disease ischemic event)