Intensification of antiretroviral therapy with raltegravir or addition of hyperimmune bovine colostrum in HIV-infected patients with suboptimal CD4 T-cell response: A randomized controlled trial

Abstract

Background.Despite virally suppressive combination antiretroviral therapy (cART), some HIV-infected patients exhibit suboptimal CD4 + T-cell recovery. This study aimed to determine the effect of intensification of cART with raltegravir or addition of hyperimmune bovine colostrum (HIBC) on CD4 + T-cell count in such patients.Methods.We randomized 75 patients to 4 treatment groups to receive raltegravir, HIBC, placebo, or both raltegravir and HIBC in a factorial, double-blind study. The primary endpoint was time-weighted mean change in CD4 + T-cell count from baseline to week 24. T-cell activation (CD38 + and HLA-DR +), plasma markers of microbial translocation (lipopolysaccharide, 16S rDNA), ..