The purpose of this trial is to determine if there is a difference between different routes of intermittently administered rhIL-2 (IV vs subcutaneous admininistration) with a highly active antiretroviral regimen compared to highly active antiretroviral therapy alone with respect to the proportion of subjects achieving a 50% increase in CD4 counts above pre-randomization baseline values after one year of rhIL-2 and the rate of change in CD4 counts. Another primary hypothesis will focus on safety, tolerance, and effect on quality of life of these regimens.
A third aim will focus on changes in immune cell phenotypes and function and on HIV viral load and rate of antiviral drug resistance development when HAART is used in the setting of rhIL-2 compared to HAART alone. The ACTG 872 Substudy will examine specific and different immunologic effects when comparing the two regimens of rhIL-2 plus HAART vs. HAART alone. The ACTG 874 substudy will determine the cellular source of HIV production in lymph node tissue before and after treatment with HAART, and the changes induced in lymph node tissue with the addition of exogenous rhIL-2, in a subset of subjects (n=12). This is a randomized study to ascertain the effect on CD4 response of high dose, intermittently administered rhIL-2 administered by continuous intravenous infusion versus subcutaneous injections in conjunction with highly active antiretroviral therapy versus highly active antiretroviral therapy alone in patients with HIV and CD4 counts of 50-300 cells/mm3. Subjects must be protease inhibitor therapy naive. All subjects will receive treatment with indinavir and 2 nucleoside analogues; one of which is new to the subject (HAART). Subjects will receive 12 weeks of HAART. At week 10 an HIV RNA by bDNA (real time) will be done by Chiron. Subjects with < 5,000 copies/ml will be continued on study. Subjects with > 5,000 copies/ml will require no further follow-up and should be taken off study. Subjects who have < 5,000 copies/ml of HIV RNA will then be randomized to continue HAART alone or HAART with rhIL-2 at either 9 million units by continuous infusion (CIV) for 5 days every 8 weeks for 72 weeks, or 9 cycles, or rhIL-2 at 7.5 million units by subcutaneous injection twice a day for 5 days every 8 weeks for 72 weeks or 9 cycles. Subjects on the CIV rhIL-2 arm who achieve both a $ 25% increase and at least a 100 cell/mm3 increase in CD4 count above the prerandomization baseline value after 3 cycles or after 6 cycles will switch to rhIL-2 at 7.5 MIU by subcutaneous injection twice a day for 5 days every 8 weeks for the remainder of their treatment course.
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