Conditions: HIV Infections
Keywords: HIV antiretroviral therapy intensification suboptimal CD4+ T cell response virological suppression bovine colostrum raltegravir
Allocation: RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 75
Healthy volunteers: no

Brief summary:
A research study to measure the effect on CD4 counts of adding to current anti-retroviral regimen raltegravir with or without hyper-immune bovine colostrum.

Detailed description:
The primary objective of this study is to measure the effect on CD4+ T cell outcome as measured by the mean time weighted CD4+ T cell count change over 24 weeks of two interventions: (I) cART intensification with raltegravir and (II) cART combined with hyper-immune bovine colostrum in HIV-1 infected individuals who have failed to achieve a CD4+ T cell count greater than 350 cells/µL despite persistent HIV plasma viraemia below 50 copies/mL on cART.

Eligible patients will be randomised to one of four arms. I. Raltegravir + hyper-immune bovine colostrum placebo II. Raltegravir placebo + hyper-immune bovine colostrum III. Raltegravir + hyper-immune bovine colostrum IV. Raltegravir placebo + hyper-immune bovine colostrum placebo

Arms:
arm 1: Raltegravir and hyper-immune bovine colostrum arm 2: Hyper-immune bovine colostrum and Raltegravir placebo arm 3: Raltegravir and Hyper-immune Bovine Colostrum Placebo arm 4: Raltegravir placebo and hyper-immune bovine colostrum placebo

Interventions: intervention 1: Raltegravir intervention 2: Hyper-immune Bovine Colostrum intervention 3: raltegravir placebo intervention 4: Hyper-immune Bovine Colostrum placebo intervention 5: raltegravir and hyper-immune bovine colostrum
Intervention descriptions: intervention 1: Tablets, 400mg, twice daily intervention 2: Tablet, 1800mg, twice daily intervention 3: One tablet, twice daily intervention 4: Three tablets twice daily intervention 5: 400mg twice daily raltegravir and 1800mg twice daily of hyper-immune bovine colostrum

Protocol document: