Death (56 events), Off Study (61 events) in panel [A]. [B] AIDS-Defining Condition (64 events), Death (27 events), Off Study (45 events). [C] Serious Non-AIDS Event (52 events), Death (30 events), Off Study (57 events).

<p>Death (56 events), Off Study (61 events) in panel [A]. [B] AIDS-Defining Condition (64 events), Death (27 events), Off Study (45 events). [C] Serious Non-AIDS Event (52 events), Death (30 events), Off Study (57 events).</p

Reported death causes, AIDS-defining conditions, and serious non-AIDS-defining events.

*<p>Total % does not add to 100% due to rounding.</p>**<p>Reported death due to AIDS without AIDS-defining condition.</p>***<p>Centers for Disease Control and Prevention 1993 AIDS-Defining Conditions.</p>****<p>Progressive Multifocal Leukoencephalopathy.</p

Multivariable competing risks analyses of times to death, new AIDS-defining conditions, and new serious non-AIDS-defining events.

<p>Multivariable competing risks analyses of times to death, new AIDS-defining conditions, and new serious non-AIDS-defining events.</p

Initiation of antiretroviral therapy (ART) results in an increase in the number of CD4+T cells and a decrease in the number of CD8+ T cells.

<div><p>Absolute CD4+ and CD8+ T cell counts were obtained in real time on fresh whole blood samples. Lymphocytes were identified by flow cytometry based on size and granularity; T cell subsets were identified by positive expression of CD4 or CD8. The numbers of circulating A) CD4+ and B) CD8+ T cells within this HIV-1 infected patient population changed significantly from baseline by day 2 (p<0.001 and p<0.002, respectively), but did not reach levels seen in healthy controls within 48 weeks of ART treatment. C) naïve (CD45RA+ CCR7+) and D) central memory (CM, CD45RA-CCR7+) CD4+ T cell numbers increased significantly by day 2 (p<0.001) and day 7 (p=0.001) respectively. Symbols used in the figure:</p> <p>N = Normal controls (in blue).</p> <p>0 = Baseline.</p> <p>D = Day (The two tick-marks between “0” and “D14” are Day 2 and Day 7).</p> <p>W = Week.</p> <p>* = Change from baseline significantly different from 0 (Wilcoxon signed rank p ≤0.05) .</p> <p>x = Significant difference from the normal controls (Wilcoxon rank sum p ≤0.05).</p> <p>- Horizontal bars represent 25^th (Q1), 50^th (Median), and 75^th percentiles.</p> <p>… Dotted line (in red) connects the medians over time.</p></div

Proportions of activated (CD38+HLA-DR+) and cycling (Ki67+) CD4+ and CD8+ T cells decreased following initiation of ART.

<div><p>Among both A) CD4+ and B) CD8+ T cell populations, initiation of raltegravir plus emtricitabine/tenofovir resulted in a significant decrease from baseline in the proportion of activated cells by 2 days and 7 days (p= 0.05 and 0.015, respectively). By week 48, the proportions of activated CD4+ and CD8+ T cells in these patients did not approach the proportions measured in healthy controls. Also among both C) CD4+ and D) CD8+ T cell populations, initiation of ART significantly decreased the proportions of Ki67+ cells by week 8 and by day 7 respectively (p<0.001 and p=0.028). E) Naïve CD4+ T cells (CD4+,CD45RA+, CCR7+) and F) CM CD4+ T cells (CD4+,CD45RA-, CCR7+) that express Ki67 were significantly reduced from baseline by week 8 (p=0.005 and p=0.001, respectively). In all four T cell subsets, proportions of Ki67+ cells did not approach the proportions seen in healthy controls by week 48 of the study. Symbols used in the figure:</p> <p>N = Normal controls (in blue).</p> <p>0 = Baseline.</p> <p>D = Day (The two tick-marks between “0” and “D14” are Day 2 and Day 7).</p> <p>W = Week.</p> <p>* = Change from baseline significantly different from 0 (Wilcoxon signed rank p ≤0.05) .</p> <p>x = Significant difference from the normal controls (Wilcoxon rank sum p ≤0.05).</p> <p>- Horizontal bars represent 25^th (Q1), 50^th (Median), and 75^th percentiles.</p> <p>… Dotted line (in red) connects the medians over time.</p></div

Markers of inflammation and coagulation are reduced following initiation of ART.

<div><p>Plasma samples were thawed and levels of A) interleukin-6 (IL-6) B) tumor necrosis factor receptor type 1 (TNFr1) C) D-dimers D) Lipopolysaccharide (LPS) and E) CD14 (sCD14) were measured. Initiation of ART resulted in significant decreases from baseline in plasma levels of IL-6 and TNFr1 by week 4 (p=0.002 and p=0.038) D-dimer levels were significantly reduced by day 7 (p=0.031). Levels of sCD14 were significantly reduced by day 2 following initiation of therapy (p<0.001). LPS levels were significantly reduced from baseline 24 weeks after initiation of ART (p<0.001). None of these markers, except for IL-6, consistently reached the levels seen in healthy controls by the end of the study. Symbols used in the figure: </p> <p>N = Normal controls (in blue).</p> <p>0 = Baseline.</p> <p>D = Day (The two tick-marks between “0” and “D14” are Day 2 and Day 7).</p> <p>W = Week.</p> <p>* = Change from baseline significantly different from 0 (Wilcoxon signed rank p ≤0.05) .</p> <p>x = Significant difference from the normal controls (Wilcoxon rank sum p ≤0.05).</p> <p>- Horizontal bars represent 25^th (Q1), 50^th (Median), and 75^th percentiles.</p> <p>… Dotted line (in red) connects the medians over time.</p></div