Phase II controlled trial of post-exposure immunization with recombinant gp160 versus antiretroviral therapy in asymptomatic HIV-1-infected adults. VaxSyn Protocol Team.
OBJECTIVE
To alter the natural course of HIV-1 infection by inducing or potentiating immune responses to HIV-1 envelope glycoprotein.


METHODS
Multicentre, double-blind, three-arm, placebo-controlled study.


METHODS
Outpatients attending clinics in two University Hospitals.


METHODS
Ninety-nine asymptomatic HIV-1-infected adults with CD4+ T-cell counts > 400 and < 600 x 10(6)/l and no previous antiretroviral therapy were included.


METHODS
Patients were randomly assigned to three groups treated with: (i) gp160 in alum over a 2-year period in combination with placebo for the full study duration (n = 32); (ii) gp160 in alum over a 2-year period in combination with zidovudine for the full study duration (n = 34); and (iii) alum over a 2-year period in combination with zidovudine for the full study duration (n = 33).


RESULTS
Immunotherapy was well tolerated and no significant differences in disease progression were seen in the treatment groups. The majority of patients (85%) receiving gp160 showed persistent lymphoproliferative responses to the immunogen and to a different Env antigen preparation. CD4+ cell count changes in patients receiving zidovudine alone were significantly higher than those seen in patients receiving immunotherapy alone after 1 year of treatment. Zidovudine administration was associated with initial transient reduction of plasma viraemia.


CONCLUSIONS
Prolonged immunization with a soluble HIV-1 subunit provided no benefit to asymptomatic HIV-1-infected patients and was inferior to zidovudine monotherapy. Furthermore, immunization with gp160 shortened the duration of the transient viral load reduction induced by zidovudine.
Pontesilli
O
O
Department of Clinical Medicine, University of Rome La Sapienza, Italy.
Guerra
E C
EC
Ammassari
A
A
Tomino
C
C
Carlesimo
M
M
Antinori
A
A
Tamburrini
E
E
Prozzo
A
A
Seeber
A C
AC
Vella
S
S
Ortona
L
L
Aiuti
F
F
D016915:AIDS Vaccines / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D018791:CD4 Lymphocyte Count; D018414:CD8-Positive T-Lymphocytes; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D005260:Female; D019302:HIV Envelope Protein gp160 / Q000276:immunology*; D015658:HIV Infections / Q000188:drug therapy / Q000276:immunology / Q000628:therapy* / Q000821:virology; D015497:HIV-1 / Q000187:drug effects; D006801:Humans; D008214:Lymphocytes / Q000276:immunology; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral / Q000097:blood; D013997:Time Factors; D014614:Vaccines, Synthetic / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D014766:Viremia; D015215:Zidovudine / Q000008:administration & dosage / Q000627:therapeutic use*
D016915:AIDS Vaccines; D019302:HIV Envelope Protein gp160; D012367:RNA, Viral; D014614:Vaccines, Synthetic; C053473:VaxSyn HIV-1 (gp160) vaccine; D015215:Zidovudine