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IL-2 Induces Sustained CD4 Cell Increases
      09/20/00 08:38 PM

IL-2 Induces Sustained CD4 Cell Increases in HIV-Infected Patients

By Deborah Mitchell

TORONTO, Sep 20 (Reuters Health) - The addition of recombinant interleukin-2 (IL-2) to an HIV antiretroviral therapy produces an increase in CD4+ T-cell counts, sustained for 12 months or longer, without having any significant effects on viral load.

These preliminary findings from the largest clinical trial to date on the safety and efficacy of IL-2 for HIV infection were presented by Dr. Donald Abrams, of the University of California, San Francisco, at the 40th Interscience Conference on Antimicrobial Agents and Chemotherapy on Monday.

"The information about the impact of IL-2 on viral load is still coming in," Dr. Abrams told conference participants.

"Originally, reports in patients receiving inadequate antiretroviral therapy suggested a six-fold increase in HIV RNA levels following a cycle of subcutaneous or intravenous IL-2," he said. Conversely, other reports have suggested that IL-2 "may lead to a purging of persistent reservoirs when given in combination with HAART." Another recent report suggested "a larger decrease in viral load at long-term follow-up in patients treated with HAART in addition to IL-2 versus antiretroviral therapy alone."

To investigate further, a multicenter trial led by Dr. Abrams was conducted as part of NIAID's Community Programs for Clinical Research on AIDS. In this phase II open-label trial, the researchers studied 511 patients with CD4+ T counts of 300 cells per microliter or greater and who were on antiretroviral therapy at baseline.

The patients "were randomized to one of two doses of subcutaneous IL-2 or no IL-2 in a 1:1:2 ratio," Dr. Abrams told his colleagues. "The two doses investigated were 4.5 or 7.5 MIU twice a day for 5 days every 8 weeks, for a minimum of 3 cycles. IL-2 was then to be given as needed to maintain CD4 cells."

Dr. Abrams concluded that "subcutaneous recombinant IL-2 given in intermittent cycles has no impact on HIV RNA levels after 12 months" in these patients. Furthermore, "a significant sustained CD4 T-cell increase is experienced in patients receiving IL-2."

These findings complement those reported in July at the XIII International AIDS Conference in Durban by Dr. H. Clifford Lane, of the National Institutes of Health, and colleagues.

"The ongoing clinical endpoint studies, SILCAAT and ESPRIT, will further define the role of IL-2 in the treatment of HIV," Dr. Abrams added.

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