title: Randomized, open-label study of the impact of two doses of subcutaneous recombinant interleukin-2 on viral burden in patients with HIV-1 infection and CD4+ cell counts of > or = 300/mm3: CPCRA 059.
abstract: The effect of intermittent courses of recombinant interleukin-2 (rIL-2) on HIV-1 load in patients receiving combination antiretroviral therapy remains uncertain. CPCRA 059 was an open-label, randomized, multicenter trial in which 511 patients with HIV-1 infection and CD4+ cell counts of > or = 300/mm3 who were receiving antiretroviral therapy were assigned to receive no rIL-2 (255 patients [controls]) or subcutaneous rIL-2 in dosages of 4.5 MIU (130) or 7.5 MIU (126) twice daily for 5-day courses every 8 weeks to maintain CD4+ cell counts that were twice the baseline value or > or = 1,000/mm3. The primary objective of this study was to compare the effects of the two doses of rIL-2 and no rIL-2 on viral load and CD4+ cell counts over 12 months. There was no difference in the following viral load measurements between the rIL-2 treatment groups and the control treatment group: percentage of patients with viral loads of <50 copies/mL at 12 months (p =.55), time to viral load of > or = 50 copies/mL for patients who had baseline viral loads of <50 copies/mL (p =.35), and change in viral load from baseline for patients who had viral loads of > or = 50 copies/mL at baseline (p =.63). At each follow-up visit, the change in CD4+ cell count from baseline was significantly greater in the rIL-2 treatment groups than in the control treatment group, with a mean difference of 251/mm3 at month 12 (95% confidence interval, 207-295; p <.0001). No unanticipated adverse experiences were seen in this trial, to our knowledge the largest randomized evaluation of rIL-2 treatment conducted to date.
authors.affiliation: San Francisco General Hospital, University of California at San Francisco, San Francisco, California 94110, USA. dabrams@php.ucsf.edu
authors.forename: Donald I
authors.initials: DI
authors.lastname: Abrams
authors.forename: Judith D
authors.initials: JD
authors.lastname: Bebchuk
authors.forename: Eileen T
authors.initials: ET
authors.lastname: Denning
authors.forename: Richard T
authors.initials: RT
authors.lastname: Davey
authors.forename: Lawrence
authors.initials: L
authors.lastname: Fox
authors.forename: H Clifford
authors.initials: HC
authors.lastname: Lane
authors.forename: James
authors.initials: J
authors.lastname: Sampson
authors.forename: Rita
authors.initials: R
authors.lastname: Verheggen
authors.forename: Douglas
authors.initials: D
authors.lastname: Zeh
authors.forename: Norman P
authors.initials: NP
authors.lastname: Markowitz
mesh_terms: D000328:Adult; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D015497:HIV-1 / Q000502:physiology*; D006801:Humans; D007279:Injections, Subcutaneous; D007376:Interleukin-2 / Q000008:administration & dosage / Q000276:immunology / Q000627:therapeutic use*; D008297:Male; D012367:RNA, Viral / Q000097:blood; D011995:Recombination, Genetic; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D007376:Interleukin-2; D012367:RNA, Viral