학술논문

The effects of an HIV-1 immunogen (Remune) on viral load, CD4 cell counts and HIV-specific immunity in a double-blind, randomized, adjuvant-controlled subset study in HIV infected subjects regardless of concomitant antiviral drugs.
Document Type
Article
Source
HIV Medicine. Apr2001, Vol. 2 Issue 2, p68-77. 10p.
Subject
*IMMUNOTHERAPY
*THERAPEUTICS
*HIV infections
*CLINICAL trials
Language
ISSN
1464-2662
Abstract
1The Graduate Hospital, 2UPHS/Presbyterian Medical Center, and 3Philadelphia Fight, Philadelphia, PA, 4Central Texas Medical Foundation, Austin, TX, 5Christiana Care, Wilmington Hospital, Wilmington, DE, 6Central Florida Research Initiative, Altamonte Springs, FL, and 7The Immune Response Corporation, Carlsbad, CA, USA Objective We examined the activity of an HIV-1 immunogen (Remune) on viral load, CD4 cells and HIV-1 specific immunity. Methods Plasma and peripheral blood mononuclear cells were obtained in a predefined random subset of subjects (n = 252) from a multicentre, double-blind, adjuvant-controlled phase III clinical endpoint study. Results The subjects treated with the HIV-1 immunogen had a significantly greater decline in viral load at multiple time points (P < 0.05), a trend towards increased CD4+ T cell counts and significantly enhanced HIV-1 specific immune responses as measured by HIV-1 lymphocyte proliferation (P < 0.001) compared to the adjuvant control group. Furthermore, in the HIV-1 immunogen treated group, enhanced HIV-1 specific lymphocyte proliferative immune responses were associated with decreased HIV-1 plasma RNA. Conclusion These results suggest that, in a predefined, random subset of subjects, a beneficial effect of the HIV-1 immunogen was observed on viral load, CD4+ T cells, and HIV-specific immunity. These differences were observed in a background of multiple drug therapies. Ongoing trials are evaluating the effect of the combination of this HIV-1 specific, immune-based therapy with potent antiviral drug therapy on virological outcomes. [ABSTRACT FROM AUTHOR]