Bergman G, Moss R, Petillo J, Slade H; International Conference on AIDS.
Int Conf AIDS. 1994 Aug 7-12; 10: 221 (abstract no. PB0314).
METHODS: HIV-1 Immunogen is a gp 120 depleted, whole inactivated virus administered in Incomplete Freud's Adjuvant (IFA). In a double-blind, randomized, IFA-controlled one year study at nine sites, 103 HIV-1 infected adults received an injections of HIV-1 Immunogen or IFA control at 0, 3, 6 months. Patients had CD4 cell counts > 550/mm3, intact humoral immunity and intact cellular immunity; none received antiretroviral therapy at study entry. Cellular and humoral immunity, viral burden (quantitative HIV-DNA by PCR) and clinical evaluations were performed every 8 weeks for one year. RESULTS: No serious adverse effects of the HIV-1 Immunogen were reported; local mild injection site reactions were common. Treated patients had a significant increase in weight from baseline not seen in controls (p = 0.028). No difference in disease progression (1993 CDC) was seen between groups. A significant increase at 32 weeks was observed for anti-p24 antibodies in treated patients compared to controls (p < 0.008). A slower rate of increase in viral burden over time occurred in treated patients vs. controls when adjusted for CD4 cell percent (p = 0.016). More treated patients had a decrease in copy numbers at study end (p = 0.033). Treated patients' lymphocytes displayed vigorous "autoproliferative" activity without exogenous antigen in T-cell proliferation assays, and displayed a greater stimulation index over time to HIV-1 Immunogen (p < 0.001) and native p24 (p < 0.007). CD4 cell counts decreased more rapidly in controls than in treated patients over time (p = 0.021). DISCUSSION: HIV-1 Immunogen in IFA demonstrated treatment effects in HIV infected adults maximally after the third injection. These potentially beneficial effects on weight gain, anti-p24 antibody titer, CD4 cell count, and viral burden suggest treatment with HIV-1 Immunogen may favorably alter the natural history of disease progression in HIV-1 infected patients. Prospective studies to assess clinical endpoints are essential to evaluate this immunotherapy in HIV-1 infected individuals.
Publication Types:
Keywords:
- AIDS Vaccines
- Acquired Immunodeficiency Syndrome
- Adjuvants, Immunologic
- Adult
- Antibody Formation
- Antigens
- CD4 Lymphocyte Count
- CD4-Positive T-Lymphocytes
- Disease Progression
- HIV Antigens
- HIV Core Protein p24
- HIV Envelope Protein gp120
- HIV Infections
- HIV Seropositivity
- HIV-1
- Humans
- Immunity, Cellular
- Lymphocyte Activation
- Prospective Studies
- Viral Load
- immunology
Other ID:
UI: 102208599
From Meeting Abstracts