HIV Cardiac Risk Reduction and CD24Fc (CALIBER)

Clinical Center

Investigators

Abstract

This study is a phase 2, randomized, placebo-control, double-blinded clinical trial to assess the safety and tolerability of CD24Fc among patients with HIV, and the effect of CD24Fc on change in low-density lipoprotein (LDL) among patients with HIV. We will also evaluate the effect of CD24Fc on total cholesterol and triglycerides, markers of immune activation (T cell activation, sCD14, and inflammatory cytokines), size of HIV reservoirs, HbA1c and leptin, and hepatic steatosis, among other inflammatory markers. We hypothesize that therapy with CD24Fc will be safe and tolerable in HIV patients on ART, and result in significant decreases in LDL. In addition, we hypothesize that CD24Fc will reduce cholesterol, leptin, HbA1c, hepatic steatosis and fibrosis, and markers of inflammation in patients with chronic HIV who are virally suppressed on ART. In this phase 2 study, a cohort of 64 HIV patients virally suppressed on ART will be randomized in a 1:1 fashion to receive an intravenous infusion of 240mg of CD24Fc vs. placebo administered every 2 weeks during a 4-week treatment window, followed by a 24- week follow-up period. Patients will be followed for safety and adverse events as well as changes in lipid metabolism and inflammatory markers during a 24-week follow-up period. This investigation will take place at the University of Maryland and National Institutes of Health. The research being completed at the National Institutes of Health Clinical Center as part of the University of Maryland study is to assess the effect of CD24Fc on aortic vascular inflammation as measured by standardized uptake value of arterial FDG by PET/CT. Twelve subjects with an LDL>125 (a high level of low-density lipoproteins (LDL), also known as bad cholesterol) will be selected to have an optional FDG PET/CT scan. Change in vascular inflammation as evidenced by aortic FDG uptake by FDG-PET/CT will be assessed before and after therapy. The arterial uptake of FDG is measured by the standardized uptake value (SUV) max divided by the venous SUV mean yielding a target to background ratio (TBR). This scan is completed twice, once before starting the study drug, and again 24 weeks after completing the study drug. The FDG PET/CT scans will help to determine if there are any changes to the levels of inflammation in the blood vessels after taking the study drug, or placebo. Enrollment has resumed following covid restrictions