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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.

Clinical Trials Registration. ClinicalTrials.gov identifier: NCT00772590, Australia New Zealand Clinical Trials Registry: ACTRN12609000575235.

© The Author 2011. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: [email protected]
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Major Articles and Brief Reports > HIV/AIDS
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