CLINICAL TRIAL: OPEN-LABEL, PH II STUDY OF INTERLEUKIN-2 AND ANTIRETROVIRAL THER

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. OBJECTIVE: To compare the change from baseline in CD4 T lymphocyte after 32 weeks in groups of patients randomly assigned to receive no therapy, subcutaneous rIL-2 monotherapy or subcutaneous rIL-2 with peri-cycle HAART. RESEARCH PLAN: This is a multi-site, phase II open label study of subcutaneous rIL-2 alone vs rIL-2 plus HAART administered only during rIL-2 cycles vs. no therapy in asymptomatic, HIV-infected patients with a CD4 T cell count of at least 300 cell/mm3. There will be three treatment arms. Eligible patients who provide consent will be randomized. METHODS: A total of 480 patients will be enrolled. Group A, 160 patients, will be randomized with no therapy. Group B, 160 patients, will be randomized with rIL-2 (7.5 MIU sc q12 hours x 5 days q8 weeks x 3 cycles, then a8 weeks as needed to maintain counts at or above goal). Group C, 160 patients, will be randomized with rIL-2 (7.5 MIU sc q12 hours x 5 days q8 weeks x 3 cycles, then q8 weeks as needed to maintain counts at or above goal) + HAART (3 days prior to, 5 days during, and 2 days after rIL-2 cycle). Patients will be followed until a common closing date which will be 12 months after the last patient is randomized. CLINICAL RELEVANCE: IL-2 is a T-cell growth factor. HIV disease is characterized by an impairment of antigen-induced IL-2 production. Progressive depletion of CD4+ T-cells is associated with an increased risk of opportunistic infections, and is the hallmark of HIV disease. When given on an intermittent schedule, IL-2 can lead to selective expansion of the CD4+ T-cell pool. These CD4+ T-cells appear to be funcitonal. Il-2 may have the potential to delay the use of HAART, the development of opportunistic infections, death, and other AIDS-defining events.