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Table 2 Clinical studies registered on https://www.clinicaltrials.govclassified as “open”, and matched search queries with the following keywords: “HIV”, “cardiovascular”, “inflammation” and/or “immune-activation” (last accession date 19 Dec 2015)

From: What happens to cardiovascular system behind the undetectable level of HIV viremia?

Official title of the study
ClinicalTrials.gov Id.
Study type and design
sponsor
Purpose and description Primary outcome measures Secondary outcome measures
A comparison of endothelial function between HIV-infected subjects not receiving anti-retroviral therapy and matched hiv-uninfected con-trol subjects
 NCT00919724
 Observational, case control, prospective
 Indiana University
The purpose of this study is to determine whether people infected with HIV have worse blood vessel function than people without HIV infection. Specifically, inflammation, immune activation, endothelial activation, and metabolic measures will be compared
This study will involve two groups of participants. The first group will consist of people with HIV who are enrolling in two other separate HIV studies (NCT00864916 and NCT00796822), one lasting 8 weeks and the other lasting 48 weeks. The second group will consist of people without HIV who are similar to the first group in terms of age, sex, smoking status, and height
Brachial artery reactivity: the maximum change in brachial artery diameter after induction of reactive hyperemia post-release of vascular occlusion Inflammatory/endothelial activation markers: (MCP-1, sVCAM-1, IL-6, TNF-a, IP-10, MMP-9, TIMP-1, PAI-1 active, hsCRP)
Peripheral blood immune activation: (percentage of CD8 +/CD38 +/HLA-DR+ T cells)
Metabolic parameters: (fasting lipoprotein fractions/triglycerides, HOMA-IR)
Biomarkers of inflammation, coagulation, and endothelial function in HIV-infected adults
 NCT00776412
 Observational, prospective
 NIAID
This study will collect information about markers of inflammation, blood clotting and blood vessel function in HIV-infected adults and healthy volunteers
Initially, the study will recruit HIV-infected adults with HIV viremia who are not taking ART and compare their clinical histories and biomarker findings with those from a group of HIV-infected adults with controlled HIV viremia who are receiving ART, and with those from a control group of HIV-negative healthy subjects. Additionally a cohort of HIV-infected adults with poor CD4 + cell recovery despite effective ART, will be enrolled (immunologic non-responder cohort) and for comparison, a control group with similar nadir CD4 counts but with good CD4+ cell recovery on ART
Not provided Not provided
Open-label, randomized, 24-week pilot study of metformin vs observation for persistent immune activation in chronic HIV infection
 NCT02383563
 Interventional, randomized
 University of Hawaii
This proposal seeks to assess the impact of 24 weeks of metformin on non-calcified plaques and calcified plaques assessed by coronary CT angiography, and on whether these changes can be explained by metformin-induced phenotypic and secretory changes of monocytes Coronary plaques by CT angiography change in total numbers of atherosclerotic plaques detected in the coronary arteries Change in numbers of each monocyte subset
Change in monocyte secretory function
Change in sub-types of coronary plaques by CT angiography (N° of calcified, non-calcified, mixed atherosclerotic coronary plaques)
Imaging companion study To ACTG A5314: effect of reducing inflammation with low dose methotrexate on inflammatory markers and endothelial function in treated and suppressed hiv infection
 NCT02312219
 Interventional, randomized
 Massachusetts general hosp
The investigators propose to conduct a time sensitive ancillary imaging study whose overall goal is to determine if treating virologically suppressed, HIV-infected individuals with low-dose methotrexate will reduce inflammation within the arterial wall. arterial FDG uptake provides a measure of inflammation in the artery wall: in fact atherosclerotic inflammation can be non-invasively and reproducibly measured with fluorodeoxyglucose (FDG)-PET/CT imaging, a well-validated quantitative technique that can sensitively detect changes in atherosclerotic inflammation and which has been employed in several multi-center trials to measure changes in arterial inflammation in response to anti-inflammatory treatments Change in arterial FDG uptake Change in splenic FDG uptake
Immunologic and inflam-matory factors and cardio-vascular risk in patients with HIV infection or autoimmune diseases
 NCT01519141
 Observational, prospective
 University of California, San Francisco
The investigators plan to obtain measurement of carotid artery intima media thickness (IMT) using high resolution ultrasound as a noninvasive means for tracking atherosclerotic progression. The investigators will also measure lipid and lipoprotein levels, inflammatory markers, markers of cytomegalovirus (CMV) infection, thrombotic markers, atherogenic lipoproteins, and markers of immune function. immunophenotyping will be performed on freshly collected blood and analyzed by flow cytometry to identify activated T-cells, T-cell turnover, proportions of T-cells, and CMV function. HIV-infected patients will have CD4 count and HIV viral load measured in addition. Patients will also go assessment of endothelial function, endothelial progenitor cells, arterial stiffness as measured using pulse wave tonometry Increased carotid intima-media thickness (mm)
Decreased brachial artery flow-mediated dilatation (%)
Increased D-dimer levels (mcg/mL)
Not provided
Effect of reducing inflam-mation with low dose metho-trexate on inflammatory mar-kers and endothelial function in treated and suppressed HIV infection
 NCT01949116
 Interventional, Randomized
 NIAID and NHLBI
People with HIV infection who are taking antiretroviral therapy may be at risk for cardiovascular disease, which can be caused by inflammation. methotrexate is a medication used to treat inflammation in people with rheumatoid arthritis. This study will evaluate the safety and effectiveness of low-dose methotrexate (LDMTX) at reducing inflammation in HIV-infected adults Change from baseline to week 24 in brachial artery flow-mediated vasodilation (FMD) (%)
(Defined as the maximum FMD (%) calculated from reactive hyperemia (RH) 60 and RH 90 relative to resting artery diameter at baseline)
(Other immune-virological and safety endpoints)
Change from baseline to week 12 in brachial artery FMD and brachial artery diameter
Change from baseline to week 24 in brachial artery diameter, brachial artery hyperemic flow velocity, levels of high-sensitivity C-reactive protein, IL-6, sCD163, D-dimer, monocyte levels, adhesion and activation indices, and CX3CR1 expression
Effect of IL–1β inhibition on inflammation and cardio-vascular risk
 NCT02272946
 Interventional, randomized
 University of California, San Francisco
The purpose of this study is to evaluate the effects of IL-1β inhibition on safety, measures of systemic and vascular inflammation and endothelial function (all indicators of cardiovascular risk) in treated and suppressed HIV infected individuals This study will assess the safety and effects of canakinumab on endothelial function (assessed by flow-mediated vasodilation [FMD] of the brachial artery), vascular inflammation (assessed by FDG-PET/CT scanning), key inflammatory markers of cardiovascular disease (CVD) risk (high-sensitivity C-reactive protein [hsCRP]), interleukin-6 (IL-6), soluble CD163 (sCD163), D-dimer, T-cell and monocyte activation in the blood, and size of the HIV reservoir. 20 individuals will receive a single dose of 150 mg canakinumab with follow-up for 18 weeks Number of adverse events at week 1, 2, 4, 8, 12, 18 as a measure of safety Change in brachial artery FMD: brachial artery FMD is calculated as the percentage increase in brachial artery diameter with hyperemia induced relative to the resting brachial artery diameter).
Change from baseline in FDG uptake assessed by FDG-PET/CT as a measure of vascular inflammation, assessed by FDG-PET/CT scanning
Rate of change in inflammatory markers of CVD risk: hsCRP, IL-6, sCD163, D-dimer, T-cell and monocyte activation in the blood, and size of the HIV reservoir
Does rosuvastatin delay progression of atherosclerosis in people with hiv infection at moderate cardiovascular risk? a multicentre rando-mized, double blind placebo-controlled Trial
 NCT01813357
 Interventional, randomized
 Bayside health
This study is a randomised double blind placebo controlled trial comparing Rosuvastatin with placebo in HIV positive people who are at intermediate cardiovascular risk
It is possible that HIV positive people will receive a greater benefit from statins because of their higher baseline levels of inflammation and this study aims to determine what benefit HIV infected people will receive from starting statin therapy earlier then currently recommended
Participants will undergo blood tests and ultrasounds of the arteries of the neck (carotid intima media thickness) prior to starting Rosuvastatin and then after 1 and 2 years on the drug to determine what effect it has on markers of inflammation, cholesterol levels and thickness of blood vessels
Progression of carotid intima media thickness. (carotid intima media thickness will be measured by ultrasonography and the change from baseline at 1 and 2 years calculated) Rates of adverse events (Number of participants with adverse events in total and also the number of participants with adverse events thought secondary to the study medication)
The effects of statin therapy on coronary flow reserve and inflammatory markers in hiv-positive patients
 NCT02234492
 Interventional, efficacy study
 Ottawa Heart Institute Research Corporation
The purpose of this study is to determine whether the use of rosuvastatin in human immunodeficiency virus (HIV) infected individuals lowers inflammation in blood vessels and improves blood circulation in the small arteries that provide nutrients to the heart muscle Correlation between coro-nary flow reserve (CFR) and maximum target to background ratio (TBR max). At baseline, corre-lation between CFR by MCE and vascular inflame-mation (TBR max) by FDG-PET/CT will be as-sessed Changes in CFR as measured by MCE will be evaluated over 6 months
Changes in vascular inflammation (TBRmax) as measured by FDG-PET/CT
Myocardial adipose inflam-mation and pericardial adipose volume as markers for coro-nary artery disease in HIV positive patients
 NCT02399384
 Observational, case control
 University of Cincinnati
The investigators propose to correlate 1) cardiac MRI pericardial adipose volume, 2) the presence of pericardial monocytes and 3) circulating immune biomarkers in persons with and without CHD and HIV infection compared to seronegative controls with known CHD. The investigators aim to test the hypothesis that higher amounts of pericardial fat deposition and increased presence of monocytes within this adipose tissue are associated with underlying coronary artery disease in persons with HIV infection as measured by cardiac MRI Pericardial adipose tissue volume Adipose spin spin relaxivity as measured by T2 star time
Evaluating the use of pitavastatin to reduce the risk of cardiovascular disease in HIV-infected adults
(REPRIEVE)
 NCT02344290
 Interventional
 National Institute of Allergy and Infectious Diseases (NIAID)
This study will evaluate the use of pitavastatin to reduce the risk of CVD in adults infected with HIV who are on antiretroviral therapy (ART).
This study will enroll adults infected with HIV who are on any ART regimen (ART is not provided by the study) for at least 6 months before study entry considered low-to-moderate risk using the 2013 American College of Cardiology (ACC)/American Heart Association (AHA) guideline thresholds for recommended statin initiation. Total study duration will be approximately 72 months from the time the first participant is enrolled
Participants will be randomly assigned to receive 4 mg of pitavastatin or placebo once a day for the entire time they are enrolled in the study
Some participants will have the option of enrolling in a substudy (effects of pitavastatin on coronary artery disease and inflammatory biomarkers: mechanistic substudy of REPRIEVE [A5333 s]). The substudy will evaluate the effect of pitavastatin on the progression of non-calcified coronary atherosclerotic plaque (NCP) and inflammatory biomarkers in adults infected with HIV. Participants in the substudy will attend study visits at study entry and months 4 and 24. The visits will include questionnaires and assessments, a blood collection, and a coronary computed tomography angiography (CCTA)
Time to the first event of a composite of major cardiovascular events
(Includes atherosclerotic or other CVD death, nonfatal myocardial infarction, unstable angina hospital-lization, coronary or peripheral arterial revascu-larization, nonfatal stroke or transient ischemic attack (TIA), urgent peripheral arterial disease (PAD) ischemic event)
Time to the first of each individual component of the primary endpoint
Time to death (all-cause mortality)
Time to death (all-cause mortality) and/or major adverse cardiovascular events (MACE)
Time to any (composite) or each (individual) of the following clinical diagnoses (Non AIDS-defining cancers; AIDS-defining events; initiation of dialysis or renal transplantation; cirrhosis, or hepatic decompensation requiring hospitalization)
Calculated fasting LDL and HDL cholesterol level
Time to any of the following adverse events (Serious adverse event, incident diabetes mellitus (DM), grade 3 or 4 ALT, or grade 3 or 4 myopathy)
  1. ART antiretroviral therapy, NIAID National Institute of Allergy and Infectious Diseases, NHLBI National Heart, Lung, and Blood Institute