Phase II controlled trial of post-exposure immunization with recombinant gp160 versus antiretroviral therapy in asymptomatic HIV-1-infected adults. VaxSyn Protocol Team.
AIDS
; 12(5): 473-80, 1998 Mar 26.
Article
em En
| MEDLINE
| ID: mdl-9543445
ABSTRACT
OBJECTIVE:
To alter the natural course of HIV-1 infection by inducing or potentiating immune responses to HIV-1 envelope glycoprotein.DESIGN:
Multicentre, double-blind, three-arm, placebo-controlled study.SETTING:
Outpatients attending clinics in two University Hospitals. PATIENTS 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.INTERVENTIONS:
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.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Vacinas Sintéticas
/
Zidovudina
/
Infecções por HIV
/
Vacinas contra a AIDS
/
Proteína gp160 do Envelope de HIV
Tipo de estudo:
Clinical_trials
/
Guideline
Limite:
Adolescent
/
Adult
/
Female
/
Humans
/
Male
/
Middle aged
Idioma:
En
Revista:
AIDS
Assunto da revista:
SINDROME DA IMUNODEFICIENCIA ADQUIRIDA (AIDS)
Ano de publicação:
1998
Tipo de documento:
Article
País de afiliação:
Itália