title: Efficacy of low-dose intermittent subcutaneous interleukin (IL)--2 in antiviral drug--experienced human immunodeficiency virus--infected persons with detectable virus load: a controlled study of 3 il-2 regimens with antiviral drug therapy.
abstract: To evaluate the safety and efficacy of 3 regimens of intermittent subcutaneous (sc) interleukin (IL)--2 in a phase 2 study, 61 antiviral drug-experienced human immunodeficiency virus (HIV)--positive patients were randomly assigned to one of the following study arms: antiretroviral therapy (ART) plus IL-2 (12 million IU [MIU] by continuous intravenous infusion, followed by 7.5 MIU twice a day, sc, every 8 weeks); ART plus IL-2 (7.5 MIU twice a day, sc, every 8 weeks); ART plus IL-2 (3 MIU twice a day, sc, every 4 weeks); or ART alone. A significant increase of circulating CD4 cells was observed in IL-2--treated subjects, compared with those given ART alone. Low doses of IL-2 were better tolerated. Despite the incomplete suppression of viral replication, IL-2 with ART did not increase either plasma viremia or cell-associated HIV DNA levels. Low doses of intermittent sc IL-2 induced a stable increase of peripheral CD4 cells that was indistinguishable from those associated with higher, less well-tolerated doses of IL-2.
authors.affiliation: Clinic of Infectious Diseases, San Raffaele Scientific Institute, 20137, Milan, Italy. giuseppe.tambussi@hsr.it
authors.forename: G
authors.initials: G
authors.lastname: Tambussi
authors.forename: S
authors.initials: S
authors.lastname: Ghezzi
authors.forename: S
authors.initials: S
authors.lastname: Nozza
authors.forename: G
authors.initials: G
authors.lastname: Vallanti
authors.forename: L
authors.initials: L
authors.lastname: Magenta
authors.forename: M
authors.initials: M
authors.lastname: Guffanti
authors.forename: A
authors.initials: A
authors.lastname: Brambilla
authors.forename: E
authors.initials: E
authors.lastname: Vicenzi
authors.forename: P
authors.initials: P
authors.lastname: Carrera
authors.forename: S
authors.initials: S
authors.lastname: Racca
authors.forename: L
authors.initials: L
authors.lastname: Soldini
authors.forename: N
authors.initials: N
authors.lastname: Gianotti
authors.forename: M
authors.initials: M
authors.lastname: Murone
authors.forename: F
authors.initials: F
authors.lastname: Veglia
authors.forename: G
authors.initials: G
authors.lastname: Poli
authors.forename: A
authors.initials: A
authors.lastname: Lazzarin
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D018791:CD4 Lymphocyte Count; D004279:DNA, Viral / Q000032:analysis; D004351:Drug Resistance; D005500:Follow-Up Studies; D005838:Genotype; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology*; D017320:HIV Protease Inhibitors / Q000627:therapeutic use; D015497:HIV-1 / Q000235:genetics / Q000302:isolation & purification; D006801:Humans; D007279:Injections, Subcutaneous; D007376:Interleukin-2 / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D007700:Kinetics; D008297:Male; D008875:Middle Aged; D018894:Reverse Transcriptase Inhibitors / Q000627:therapeutic use; D013601:T-Lymphocytes / Q000821:virology; D019562:Viral Load; D014766:Viremia / Q000188:drug therapy / Q000276:immunology / Q000821:virology
chemical_list: D019380:Anti-HIV Agents; D004279:DNA, Viral; D017320:HIV Protease Inhibitors; D007376:Interleukin-2; D018894:Reverse Transcriptase Inhibitors