PMID- 10068580 OWN - NLM STAT- MEDLINE DCOM- 19990421 LR - 20211115 IS - 0022-1899 (Print) IS - 0022-1899 (Linking) VI - 179 IP - 4 DP - 1999 Apr TI - A randomized trial of high- versus low-dose subcutaneous interleukin-2 outpatient therapy for early human immunodeficiency virus type 1 infection. PG - 849-58 AB - Forty-nine outpatients infected with human immunodeficiency virus with baseline CD4 cell counts >/=500/mm3, who were on stable antiretroviral therapy, were randomized to receive 5-day cycles of either low-dose (1.5 million IU [MIU] twice a day) or high-dose (7.5 MIU twice a day) subcutaneous (sc) interleukin (IL)-2 every 4 or every 8 weeks. High-dose recipients experienced mean slopes of +116.1 cells/month and +2.7 %/month in CD4 cells and percents, respectively, whereas low-dose recipients displayed mean slopes of +26.7 and +1.3% in the same parameters. At month 6, high-dose recipients achieved a 94.8% increase in mean CD4 cells over baseline compared with a 19.0% increase in low-dose recipients. While high-dose recipients encountered more constitutional side effects, these were generally not dose-limiting. High-dose scIL-2 therapy in outpatients with early HIV-1 infection was well tolerated and induced dramatic, sustained rises in CD4 cells. FAU - Davey, R T Jr AU - Davey RT Jr AD - National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20892-1880, USA. rdavey@atlas. niaid.nih.gov FAU - Chaitt, D G AU - Chaitt DG FAU - Albert, J M AU - Albert JM FAU - Piscitelli, S C AU - Piscitelli SC FAU - Kovacs, J A AU - Kovacs JA FAU - Walker, R E AU - Walker RE FAU - Falloon, J AU - Falloon J FAU - Polis, M A AU - Polis MA FAU - Metcalf, J A AU - Metcalf JA FAU - Masur, H AU - Masur H FAU - Dewar, R AU - Dewar R FAU - Baseler, M AU - Baseler M FAU - Fyfe, G AU - Fyfe G FAU - Giedlin, M A AU - Giedlin MA FAU - Lane, H C AU - Lane HC LA - eng PT - Clinical Trial PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, U.S. Gov't, P.H.S. PL - United States TA - J Infect Dis JT - The Journal of infectious diseases JID - 0413675 RN - 0 (Interleukin-2) SB - IM MH - Acquired Immunodeficiency Syndrome/immunology/*therapy/virology MH - Adult MH - CD4 Lymphocyte Count MH - Dose-Response Relationship, Drug MH - Female MH - Follow-Up Studies MH - *HIV-1 MH - Humans MH - Injections, Subcutaneous MH - Interleukin-2/*administration & dosage/adverse effects/pharmacokinetics MH - Male MH - Middle Aged EDAT- 1999/03/09 03:00 MHDA- 2000/03/21 09:00 CRDT- 1999/03/09 03:00 PHST- 1999/03/09 03:00 [pubmed] PHST- 2000/03/21 09:00 [medline] PHST- 1999/03/09 03:00 [entrez] AID - JID980938 [pii] AID - 10.1086/314678 [doi] PST - ppublish SO - J Infect Dis. 1999 Apr;179(4):849-58. doi: 10.1086/314678.