[O24] A RANDOMISED, OPEN-LABEL, PHASE I TRIAL OF HIGHLY ACTIVE ANTIRETROVIRAL THERAPY (HAART) COMBINED WITH INTERLEUKIN-2 (IL-2) AND/OR AN INACTIVATED GP120 DEPLETED HIV-1 IMMUNOGEN (REMUNE)

8th Annual Conference Of The British HIV Association [BHIVA]

19 – 21 April 2002, University of York, York

[TITLE:] A RANDOMISED, OPEN-LABEL, PHASE I TRIAL OF HIGHLY ACTIVE ANTIRETROVIRAL THERAPY (HAART) COMBINED WITH INTERLEUKIN-2 (IL-2) AND/OR AN INACTIVATED GP120 DEPLETED HIV-1 IMMUNOGEN (REMUNE)

[AUTHOR(S):] G Hardy¹, N Imami¹, A Sullivan¹, M Nelson¹, C Burton¹, J Pido-Lopez¹, R Moss², BG Gazzard¹ and F Gotch¹
¹ Imperial College School of Medicine, Chelsea and Westminster Hospital, London, UK, and ² Immune Response Corporation, San Diego, CA, USA

BHIVA Conf 2002 Apr 19-21;8:O24

OBJECTIVE: To enhance HIV-1-specific CD8 cytotoxic T-lymphocyte (CTL) and CD4 helper T-lymphocyte (HTL) responses following cessation of HIV-1 activity by HAART using combination immunotherapy.

METHODS: A randomized, phase I study of HAART in combination with IL-2 and/or Remune in advanced chronically infected patients (mean baseline CD4 T-cell count 303 cells/µL blood) was conducted. 36 patients were treated with HAART for 16 weeks before randomization to: (A) HAART alone (n=9); (B) HAART + IL-2 (n=11); (C) HAART + IL-2 + Remune (n=7); (D) HAART + Remune (n=9).

RESULTS: While HAART is insufficient to allow regeneration of HIV-1- specific responses, specific factors allow transient regeneration of these responses. Most significantly, therapeutic failure leading to virological breakthrough induced strong CD4 HTL and CD8 CTL T-cell responses to HIV-1 in the context of immunotherapy. Recall CD4 HTL responses improved upon therapy with IL-2. IL-2 substantially increased CD4 T-cell counts. IL-2 induced transient viraemia that was seen predominantly in group B, but less in group C patients. No changes in plasma macrophage inflammatory protein (MIP)-1α levels were seen for any patients in the study. T-cell receptor excision circle levels were significantly reduced in patients receiving IL-2 (P<0.05).

CONCLUSION: Overall, no differences were seen in the induction of HIV-1 CD4 HTL or CD8 CTL responses between those receiving IL-2 and/or Remune, despite an apparent protective effect against virological events by their combination.

PRESENTING AUTHOR: G Hardy

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