Figure 3. Change point model of log plasma viral load (LogVL) and CD4 for Phase II macaques.
(A) ΔCD4 for SIVsmB7 treated macaques was significantly higher than in CEM mock control. By 14 DPI, there was mean loss of −355.8 CD4/μl in SIVsmB7 treated animals compared to −120.4 CD4/μl for controls (Student’s T-Test: p=0.0268 [inset]). (B) Twenty-two of 24 Macaques in both treatment arms reached peak viral load on days 14 or 21. Four of the CEM macaques had significantly lower log viral loads than the remaining eight CEM mock macaques [t-test on Area Under Curve (AUC) with p<0.0001], which was not explained by known correlates of spontaneous SIV control or protection suggesting low viral load was normal variation. At no time point was difference in Log viral load significant, however starting at 14 DPI and ending at 42 DPI there was a trend towards increased viremia in SIVsmB7 inoculated macaques (Student’s T-Test: p=0.118). (C) As we detected a significant difference in ΔCD4 between groups, we generated a linear mixed effect spline model to investigate CD4 change between treatment groups over time (in days, as “DPI”). This model predicts an increased loss of CD4+ T-Cells per day of 14.5 cells/μl over top of the CEM mock control animals culminating at peak viremia (day 14). (D) To investigate the behavior of log viral viral load a linear mixed effect spline model for LogVL was also generated. The LogVL model predicts SIVsmB7-treated animals to have an increased log viral load rise per day of 0.106 over top of CEM mock treated animals up until peak viremia on day 14.
