title: A randomized controlled trial evaluating the efficacy and safety of intermittent 3-, 4-, and 5-day cycles of intravenous recombinant human interleukin-2 combined with antiretroviral therapy (ART) versus ART alone in HIV-seropositive patients with 100-300 CD4+ T cells.
abstract: The effect of length of therapy on the safety and efficacy profile of continuous intravenous (CIV) interleukin-2 (IL-2) in combination with antiretroviral therapy (ART) was evaluated in 81 HIV-seropositive patients with CD4(+) T-cell counts of 100-300/mm(3). Patients were randomized to CIV IL-2 (12 mIU/day) for 3, 4, or 5 days plus ART every 8 weeks for six cycles, or to ART alone. The mean percent increase in CD4(+) T-cell counts was 24.5% for IL-2 recipients compared with a mean percent decrease of 30.5% for control patients (P = 0.005). Increasing duration of CIV IL-2 therapy resulted in improved CD4(+) T-cell response. The most frequent clinical adverse events and laboratory abnormalities were predominantly of grade 1 or 2 severity. However, grade 3 or 4 events were reported in 57%, 60%, and 84% of the 3-, 4-, and 5-day CIV IL-2 patients, respectively. Serious adverse events, mainly due to the requirement of hospitalization, occurred in 20% of IL-2 recipients, compared with 10% of control patients. Viral load during the course of the study was not different among the treatment groups. IL-2 therapy in cycles of 5 days resulted in an optimal increase in CD4(+) T-cell counts and is the preferred cycle length for IL-2 therapy geared toward increasing CD4(+) T-cell numbers.
authors.affiliation: Chiron Corporation, Emeryville, CA 94608-2916, USA. corine_de_boer@chiron.com
authors.forename: Alberdina W
authors.initials: AW
authors.lastname: de Boer
authors.forename: Norman
authors.initials: N
authors.lastname: Markowitz
authors.forename: H Clifford
authors.initials: HC
authors.lastname: Lane
authors.forename: Louis D
authors.initials: LD
authors.lastname: Saravolatz
authors.forename: Susan L
authors.initials: SL
authors.lastname: Koletar
authors.forename: Haig
authors.initials: H
authors.lastname: Donabedian
authors.forename: Carl
authors.initials: C
authors.lastname: Yoshizawa
authors.forename: Anne-Marie
authors.initials: AM
authors.lastname: Duliege
authors.forename: Gwendolyn
authors.initials: G
authors.lastname: Fyfe
authors.forename: Ronald T
authors.initials: RT
authors.lastname: Mitsuyasu
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents; D018791:CD4 Lymphocyte Count; D004359:Drug Therapy, Combination; D005260:Female; D006679:HIV Seropositivity / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D006801:Humans; D007275:Injections, Intravenous; D007376:Interleukin-2 / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins / Q000008:administration & dosage; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D007376:Interleukin-2; D012367:RNA, Viral; D011994:Recombinant Proteins