Antiretroviral therapy intensification with raltegravir and/or hyper-immune bovine colostrum in Human Immunodeficiency Virus-1 (HIV-1) infected patients with suboptimal immunological response

INTERVENTION: Intensification of antiretroviral therapy with oral raltegravir and or oral hyper‐immune bovine colostrum 48 weeks. Particiapants be be randomly allocated to one of four arms of the study I. Raltegravir 400mg (1 tablet) twice daily + hyper‐immune bovine colostrum placebo (3 tablets) twice daily II. Raltegravir placebo (1 tablet) twice daily + hyper‐immune bovine colostrum 1800mg (3 tablets) twice daily III. Raltegravir 400mg (1 tablet) twice daily + hyper‐immune bovine colostrum 1800mg (3 tablets) twice daily IV. Raltegravir placebo (1 tablet) twice daily + hyper‐immune bovine colostrum placebo (3 tablets) twice daily CONDITION: Human Immunodeficiency Virus (HIV)Infection PRIMARY OUTCOME: Change from baseline of CD4+ T cell count of comparisons 1) raltegravir versus placebo and 2) hyper‐immune bovine colostrum versus placebo as measured in peripheral blood SECONDARY OUTCOME: Change in T cell count, T cell percentage, activated T cells, microbial translocation markers, plasma HIV Ribonucleic Acid (RNA) ‐ with limit of detection of 0.4 HIV RNA copies/mL, immune activation markers and proportion of patients with CD4+ T cells greater than 350 cells/microlitre over 48 weeks INCLUSION CRITERIA: 1. Documented HIV‐1 infection 2. Age >18 years 3. Signed informed consent 4. Receiving combination ART for at least 12 months with a stable cART regimen for a minimum of 6 months. 5. Two consecutive plasma HIV RNA viral load measurements <50 in the 9 months preceding the screening visit. 6. CD4+ T cell count <350 cells/µL throughout the 6 months preceding the screening visit with <50 cells/µL increase in the last 12 months