Therapeutic vaccination (p24-VLP) of patients with advanced HIV-1 infection in the pre-HAART era does not alter CD4 cell decline.
In a randomized placebo controlled trial 304 HIV infected patients with CD4 cell counts below 350 cells/microL received therapeutic vaccination with: alum placebo (Group I, n = 102), p24-VLP 500 microg (Group II, n = 101) or p24-VLP 1000 microg (Group III, n = 101) p24-VLP monthly for six months. Over one year the average change in CD4 cell count did not differ significantly between groups (-32, -40 and -52 cells per microL respectively). There was also no difference between groups in progression to CDC category 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.
Smith
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National Centre in HIV Epidemiology and Clinical Research, University of New South Wales, Sydney, Australia. don.smith@unsw.edu.au
Gow
I
I
Colebunders
R
R
Weller
I
I
Tchamouroff
S
S
Weber
J
J
Boag
F
F
Hales
G
G
Adams
S
S
Patou
G
G
Cooper
D A
DA
D016915:AIDS Vaccines / Q000008:administration & dosage / Q000276:immunology* / Q000627:therapeutic use*; D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D003131:Combined Modality Therapy; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D016655:HIV Core Protein p24 / Q000008:administration & dosage / Q000276:immunology* / Q000627:therapeutic use*; D015658:HIV Infections / Q000145:classification / Q000276:immunology* / Q000401:mortality / Q000628:therapy*; D015497:HIV-1; D006801:Humans; D008297:Male; D012720:Severity of Illness Index; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome
D016915:AIDS Vaccines; D019380:Anti-HIV Agents; D016655:HIV Core Protein p24; C065031:p24-VLP vaccine