In a randomized placebo controlled trial 304 HIV infected patients with CD4 cell counts below 350 cells/µL received monthly therapeutic vaccination for 6 months with: alum placebo (Group I, n = 102), p24-VLP 500 µg (Group II, n = 101) or p24-VLP 1000 µg (Group III, n = 101). Over one year the average change in CD4 cell count did not differ significantly between groups (–32, –40 and –52 cells per μL respectively). There was also no difference between groups in progression to CDC catagory B or C events, or in adverse events. Therapeutic vaccination with p24-VLP does not affect CD4 cell decline in patients with advanced HIV infection.
HIV Medicine (2001)Volume 2 Issue 4, Pages 272 - 275 [doi:10.1046/j.1468-1293.2001.00080.x]
Therapeutic vaccination (p24-VLP) of patients with advanced HIV-1 infection in the pre-HAART era does not alter CD4 cell decline