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

Byakwaga, Helen, Kelly, Mark, Purcell, Damian F. J., French, Martyn A., Amin, Janaki, Lewin, Sharon R., Haskelberg, Hila, Kelleher, Anthony D., Garsia, Roger, Boyd, Mark A., Cooper, David A. and Emery, Sean (2011) 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. Journal of Infectious Diseases, 204 10: 1532-1540. doi:10.1093/infdis/jir559


Author Byakwaga, Helen
Kelly, Mark
Purcell, Damian F. J.
French, Martyn A.
Amin, Janaki
Lewin, Sharon R.
Haskelberg, Hila
Kelleher, Anthony D.
Garsia, Roger
Boyd, Mark A.
Cooper, David A.
Emery, Sean
Title 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
Journal name Journal of Infectious Diseases   Check publisher's open access policy
ISSN 0022-1899
1537-6613
Publication date 2011-11-15
Sub-type Article (original research)
DOI 10.1093/infdis/jir559
Open Access Status Not yet assessed
Volume 204
Issue 10
Start page 1532
End page 1540
Total pages 9
Place of publication Cary, NC, United States
Publisher Oxford University Press
Language eng
Formatted 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.
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collection: School of Medicine Publications
 
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