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- Title
Low-Dose Prolonged Intermittent Interleukin-2 Adjuvant Therapy: Results of a Randomized Trial among Human Immunodeficiency Virus-Positive Patients with Advanced Immune Impairment.
- Authors
Marchetti, Giulia; Meroni, Luca; Varchetta, Stefania; Terzieva, Velislava; Bandera, Alessandra; Manganaro, Daniele; Molteni, Chiara; Trabattoni, Daria; Fossati, Sabrina; Clerici, Mario; Galli, Massimo; Moroni, Mauro; Franzetti, Fabio; Gori, Andrea
- Abstract
Twenty-two patients with CD4[sup +]cell counts ≤200 cells/µL after 12 months of stable highly active antiretroviral therapy (HAART; "immunologic nonresponders") were randomly assigned to receive subcutaneous low-dose prolonged intermittent interleukin (IL)-2 in addition to HAART (n = 12) or to continue HAART alone (n = 10). At 48 weeks of follow-up, no IL-2-related serious adverse events and no significant differences in plasma human immunodeficiency virus (HIV) RNA level were observed in the 2 groups. A higher incidence of HIV-related clinical events was observed among patients receiving HAART alone (3/10) than among subjects receiving HAART plus IL-2 (0/12). Significant increases in CD4[sup +], naive, and CD4[sup +]CD7[sup +] cells and plasma levels of IL-7 were observed in patients receiving IL-2 versus patients receiving HAART alone. A significant increase in cell turnover did not lead to a decrease in the frequency of T cell receptor excision circles, which remained stable. Rather, increased numbers of T cell receptor excision circles per microliter of blood were observed (not statistically significant). Thus, adjuvant IL-2 therapy in immunologic nonresponders resulted in a clinical benefit, suggesting that the quantitative cell recovery involves functionally competent immune cells.
- Subjects
HIV-positive persons; INTERLEUKIN-2; THERAPEUTICS
- Publication
Journal of Infectious Diseases, 2002, Vol 186, Issue 5, p606
- ISSN
0022-1899
- Publication type
Article
- DOI
10.1086/342479