Phase II controlled trial of post-exposure immunization with recombinant gp160 versus antiretroviral therapy in asymptomatic HIV-1-infected adults. VaxSyn Protocol Team

• Published in: AIDS (London) Vol. 12; no. 5; pp. 473 - 480
• Main Authors: Pontesilli, O, Guerra, E C, Ammassari, A, Tomino, C, Carlesimo, M, Antinori, A, Tamburrini, E, Prozzo, A, Seeber, A C, Vella, S, Ortona, L, Aiuti, F
• Format: Journal Article
• Language: English
• Published: England 26-03-1998
• Subjects: Adolescent; Adult; AIDS Vaccines - adverse effects; AIDS Vaccines - immunology; AIDS Vaccines - therapeutic use; AIDS/HIV; CD4 Lymphocyte Count; CD8-Positive T-Lymphocytes; Combined Modality Therapy; Double-Blind Method; Female; HIV Envelope Protein gp160 - immunology; HIV Infections - drug therapy; HIV Infections - immunology; HIV Infections - therapy; HIV Infections - virology; HIV-1 - drug effects; Humans; Lymphocytes - immunology; Male; Middle Aged; RNA, Viral - blood; Time Factors; Vaccines, Synthetic - adverse effects; Vaccines, Synthetic - immunology; Vaccines, Synthetic - therapeutic use; Viremia; Zidovudine - administration & dosage; Zidovudine - therapeutic use
• ISSN: 0269-9370

To alter the natural course of HIV-1 infection by inducing or potentiating immune responses to HIV-1 envelope glycoprotein.
Multicentre, double-blind, three-arm, placebo-controlled study.
Outpatients attending clinics in two University Hospitals.
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.
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).
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.
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.