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A quick look at the many recently published studies about Interleukin-2 (IL-2) therapy among HIV-infected patients clearly shows the popularity of this new approach to treatment. Investigators from universities, government agencies, pharmaceutical companies, and other research centers around the world are studying IL-2 treatment.
Here is a brief summary of some of the more recently published studies:
• The National Institutes of Health (NIH) in Bethesda, MD, and Italian researchers evenly divided a group of 12 HIV-infected people between those who received IL-2 treatment with antiretroviral therapy and those who received antiretroviral therapy alone. The groups were matched for CD4 cell counts, viral load, and duration of antiretroviral therapy. After 30 days, the IL-2 treatment reduced viral isolation despite increasing CCR5 expression, suggesting that the combination of IL-2 and antiretroviral therapy may improve host defenses against HIV in patients receiving antiretroviral therapy.1
• A study of 115 patients showed a dramatic effect of daily, subcutaneous, low-dose IL-2 on the natural killer cell population, with increases significantly greater than a control group that did not receive IL-2 therapy. IL-2-treated patients also experienced a 3.52% increase in the mean percentage of CD4 T-cells, compared with a 1.33% increase among the control group. HIV-infected subjects receiving the daily, low-dose IL-2 therapy had substantially fewer adverse events than what is commonly experienced by patients on intermittent, high-dose IL-2 therapy.2
• Researchers at Weill Medical College at Cornell University in New York studied in vivo antiviral activity before and after treatment interruption among patients who received low-dose IL-2 therapy. They found that plasma viral relapse occurred in all participants, reaching peak concentration at 2.5 weeks, but over the subsequent two weeks viremia was reduced. The study concluded that in vivo antiviral reactivity after antiviral interruption can be useful in monitoring the efficacy of different therapies.3
• California and Boston investigators conducted a randomized trial of IL-2 added to highly active antiretroviral therapy (HAART) and found that HIV-infected patients achieved higher CD4 cell counts when IL-2 was added to HAART.4
• Paris investigators found that treatment with intermediate doses of IL-2 combined with HAART resulted in a greater increase of CD4 cells than treatment with HAART alone.5
• Another NIH study of IL-2 plus HAART vs. HAART alone concluded that treatment with IL-2 added to HAART results in a significant enhancement of CD4 T-cells in the periphery, while there is no change in replication-competent HIV in resting CD4 T-cells compared with patients treated with HAART alone over a 12-month period of follow-up.6
• A large prospective randomized study of IL-2 in advanced HIV patients found significant increases in CD4 cell counts associated with both continuous intravenous and subcutaneous IL-2 compared to HAART alone after 60 weeks of therapy. The CD4 cell count continued to increase to week 84.7
1. Oliva A, Kinter A, Rabin R, et al. CCR5 expression, CC-Chemokine production and viral isolation in HIV-infected individuals receiving HAART or HAART + IL-2. Abstract 68 presented at the 8th Conference on Retroviruses and Opportunistic Infections. Chicago; Feb. 4-8, 2001.
2. Lalezari JP, Beal JA, Ruane PJ, et al. Low-dose daily subcutaneous Interleukin-2 in combination with highly active antiretroviral therapy in HIV+ patients: A randomized control trial. HIV Clinical Trials 2000; 1:1-15.
3. Smith KA, Jacobson EL, Sohn T, et al. In vivo assessment of antiviral reactivity in chronic HIV infection. HIV Clinical Trials 2000; 1:16-22.
4. Hecht FM, Levy JA, Martinez-Marino B, et al. A randomized trial of Interleukin-2 (IL-2) added to HAART for primary HIV. Abstract 407 presented at the 8th Conference on Retroviruses and Opportunistic Infections. Chicago; Feb. 4-8, 2001.
5. Levy Y, Capitant C, Lascaux AS, et al. Effect of subcutaneous (SC) IL-2 therapy combined with HAART in HIV-infected patients. Results of the ANRS 079 randomized trial. Abstract 344 presented at the 8th Conference on Retroviruses and Opportunistic Infections. Chicago; Feb. 4-8, 2001.
6. Dybul M, Belson CM, Hidalgo B, et al. A randomized, controlled pilot study of HAART vs. HAART plus IL-2 for the treatment of recently acquired HIV infection. Abstract 406 presented at the 8th Conference on Retroviruses and Opportunistic Infections. Chicago; Feb. 4-8, 2001.
7. Mitsuyasu R, Pollard R, Gelman R, et al. Prospective, randomized, controlled phase II study of highly active antiretroviral therapy (HAART) with continuous IV (CIV) or subcutaneous (SC) Interleukin-2 (IL-2) in HIV-infected patients with CD4+ counts of 50-350 cells/mm3: ACTG 328-final results at 84 weeks. Abstract 17 presented at the 8th Conference on Retroviruses and Opportunistic Infections. Chicago; Feb. 4-8, 2001.