Progressive disease due to HIV infection is characterized by a decline in CD4+ lymphocytes and a rise in viral burden (amount of HIV in blood and tissues), typically occurring gradually over years. Several studies have revealed that intermittent infusions of the lymphokine, interleukin-2 (IL-2), in combination with reverse transcriptase inhibitors, can lead to marked increases in CD4 counts in some patients to a degree that was unprecendented with antiretroviral therapy alone. Other recent data demonstrate the success of using highly active antiretroviral therapy (HAART; for example, 2 nucleoside-analog reverse transcriptase inhibitors and 1 HIV-1 protease inhibitor) in substantially lowering viral burden and delaying progression to AIDS or death. ACTG 328 is a randomized multicenter study to evaluate the effects of combining these promising antiretroviral (HAART) and immunomodulatory (IL-2) strategies compared with administering HAART alone among 150 patients with 50-300 CD4 cells/mm3. UAB investigators originally proposed and developed the lymph node sub-study (ACTG 874), in which serial lymph node biopsies will be carried out in order to correlate immunologic/virologic changes between blood and lymphoreticular tissues. These same UAB investigators are co-chairs for this substudy, and the emphasis at UAB will be to enroll most or all of the ACTG 874 sub-study participants at this one site.
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