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

Helen Byakwaga, Mark Kelly, Damian F.J. Purcell, Martyn A. French, Janaki Amin, Sharon R. Lewin, Hila Haskelberg, Anthony D. Kelleher, Roger Garsia, Mark A. Boyd, David A. Cooper, Sean Emery

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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), monocyte activation (soluble (s) CD14), and HIV-RNA (lowest level of detection 4 copies/mL) were monitored. Analysis was performed using linear regression methods.Results. Compared with placebo, the addition of neither raltegravir nor HIBC to cART for 24 weeks resulted in a significant change in CD4 + T-cell count (mean difference, 95% confidence interval [CI]: 3.09 cells/μL, -14.27; 20.45, P =. 724 and 9.43 cells/μL, -7.81; 26.68, P =. 279, respectively, intention to treat). There was no significant interaction between HIBC and raltegravir (P =. 275). No correlation was found between CD4 + T-cell count and plasma lipopolysaccharide, 16S rDNA, sCD14, or HIV-RNA.Conclusion.The determinants of poor CD4 + T-cell recovery following cART require further investigation.

Original languageEnglish
Pages (from-to)1532-1540
Number of pages9
JournalJournal of Infectious Diseases
Volume204
Issue number10
DOIs
Publication statusPublished - 15 Nov 2011

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