home





























 

















 





















hrsa

participating institutions:
Johns Hopkins University AIDS Service, New York State DOH AIDS Institute, The CORE Center, Cook County Hospital



NEWS AND NEW DEVELOPMENTS



Low-Dose Daily Subcutaneous Interleukin-2 in Combination with Highly Active Antiretroviral Therapy in HIV+ Patients: A Randomized Controlled Trial [Lalezari JP, et al. HIV Clin Trials 299911(3):1]: This is a randomized trial of 115 patients including 56 asymptomatic patients with CD4 cell counts <300/mm3 and viral loads <500 c/mL on HAART at baseline. The treatment group received 1.2 MIU/m2 IL-2 daily for two weeks with the investigator option to increase the dose by increments of 0.3 MIU/m2 every two weeks until there was a grade 2 toxicity. There were 56 patients randomized to HAART plus IL-2 of whom 23 withdrew and 32 completed the 26-week trial. The most dramatic effect of IL-2 therapy was the increase in natural killer (NK) cells with mean increases of 156/mm3 for IL-2 recipients compared to 20/mm3 in controls. There was also a significant increase in the mean percent of CD4 cells (3.5% versus 1.3% in controls) and an expanded population of the CD4 cell naïve phenotype (4.5% versus 0.3%). All of these differences were statistically significant; the difference in absolute CD4 cell counts at 26 weeks showed a mean increase of 53/mm3 in IL-2 recipients compared to 35/mm3 in the control group, and this difference was not statistically significant. The authors concluded that daily, low-dose FC IL-2 therapy with HAART is safe, well tolerated, and also effectively expands NK cells and naïve CD4 cells among patients with CD4 cell counts <300/mm3.
Comment: There are many studies of IL-2, which generally show expansion of the CD4 cell count that can be substantial, especially when the initial count is >300/mm3 . A major limitation in these trials has been toxicity of IL-2. The present report shows a lower dose was reasonably well tolerated, although daily SC injections were required, and the increase in the absolute CD4 cell count was modest and not statistically significant. A concern about this trial is the relatively high dropout rate, which was 41% in the IL-2 group compared to 7% in controls. Nevertheless, those who completed the study showed an expansion of NK cells and naïve CD4 cells and an increase in the CD4 cell percentage. What is lacking in the multiple IL-2 trials to date is any demonstration of clinical benefit in terms of outcomes.
posted 1/4/2001





Copyright © 2001-2002. The National AIDS Education and Training Centers Program on behalf of its AETC National Resource Center. All rights reserved.

Physicians and other health care professionals are encouraged to consult other sources and confirm the information contained in this site because no single reference or service can take the place of medical training, education, and experience. Consumers are cautioned that this site is not intended to provide medical advice about any specific medical condition they may have or treatment they may need, and they are encouraged to call or see their physician or other health care provider promptly with any health related questions they may have.