This is an ongoing randomized open-label multicenter clinical trial involving intermittent fhIL-2 (continuous infusion or subcutaneous injections) in combination with highly active antiretroviral therapy (HAART) in HIV-infected patients with CD4 counts between 50 and 350 cells/cmm. Approximately 134 of the proposed 150 patients have been enrolled nationwide. The UAB site, along with the Duke University site, aimed to enroll 12 patients into an additional substudy to analyze serial lymph node tissue biopsies for this same group of subjects. The UAB site has enrolled a total of 10 subjects into ACTG 328, 9 of whom have undergone lymph node biopsies as part of the ACTG 874 sub-study. Initial analyses of these biopsied tissues have resulted in new insights regarding the pathogenesis of HIV infection: 1)HIV-infected cells produce a constant amount of virus regardless of treatment status or stage of disease (submitted for publication) and 2) the initial rise in CD4 counts among patients receiving HAART is due to redistribution of cells, not the generation of new cells (manuscript in preparation). Future plans include the continued analysis of blood and tissues as well as descriptions of the clinical course of these patients as they receive multiple cycles of IL-2 therapy.
Showing the most recent 10 out of 570 publications
