A pilot trial of pentoxifylline on endothelial function and inflammation in HIV-infected patients initiating antiretroviral therapy.

In a single-arm, open-label, eight week, pilot study, we reported that pentoxifylline (PTX) reduced circulating levels of interferon-γ-induced protein 10 (IP-10) and soluble vascular cell adhesion molecule-1 (sVCAM-1) and improved endothelial function (measured as flowmediated dilation (FMD) of the brachial artery) in HIV-infected patients not receiving ART [4]. However, in a randomized, placebo-controlled trial of PTX in a similarly untreated population, we did not confirm that PTX reduced inflammation or improved endothelial function [5]. In fact, PTX unexpectedly led to significantly increased circulating soluble tumor necrosis factor-1 (sTNFR1) levels compared to placebo in this trial. However, the potential effects of PTX on FMD and inflammation in a population initiating ART are unknown. Thus, we conducted a randomized, placebo-controlled, single-center pilot trial of PTX 400mg thrice daily given for 48 weeks in patients concurrently initiating ART (ClinicalTrials.gov NCT00864916).