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

J Infect Dis. 2011 Nov 15;204(10):1532-40. doi: 10.1093/infdis/jir559. Epub 2011 Sep 19.


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

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Animals
  • CD4 Lymphocyte Count
  • CD4-Positive T-Lymphocytes / drug effects*
  • CD4-Positive T-Lymphocytes / metabolism
  • Cattle
  • Colostrum* / immunology
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • HIV / immunology
  • HIV / isolation & purification
  • HIV Infections / blood
  • HIV Infections / drug therapy*
  • HIV Infections / immunology*
  • HIV Integrase Inhibitors / pharmacology*
  • HIV Integrase Inhibitors / therapeutic use
  • Humans
  • Linear Models
  • Lymphocyte Activation
  • Male
  • Middle Aged
  • Pregnancy
  • Pyrrolidinones / pharmacology*
  • Pyrrolidinones / therapeutic use
  • RNA, Viral / blood
  • Raltegravir Potassium


  • HIV Integrase Inhibitors
  • Pyrrolidinones
  • RNA, Viral
  • Raltegravir Potassium

Associated data