PMID- 18279104
OWN - NLM
STAT- MEDLINE
DCOM- 20080414
LR  - 20130527
IS  - 1079-9907 (Print)
IS  - 1079-9907 (Linking)
VI  - 28
IP  - 2
DP  - 2008 Feb
TI  - Safety, tolerability, pharmacokinetics, and efficacy of an interleukin-2 agonist 
      among HIV-infected patients receiving highly active antiretroviral therapy.
PG  - 89-100
LID - 10.1089/jir.2007.0064 [doi]
AB  - We sought to determine the safety, maximum tolerated dose, optimal dose, and 
      preliminary dose efficacy of intermittent subcutaneously (s.c.) administered BAY 
      50-4798 among patients with HIV infection receiving highly active antiretroviral 
      therapy (HAART) compared with patients receiving HAART alone. A phase I/II 
      randomized, double-blind, dose-escalation study was conducted of the safety, 
      tolerability, pharmacokinetics, and efficacy of s.c. BAY 50-4798 administered to 
      HIV-infected patients already receiving stable HAART. There were no unexpected 
      safety findings in a population of HIV-infected patients receiving HAART plus SC 
      BAY 50-4798 as adjunctive therapy. BAY 50-4798 exhibited nearly dose-proportional 
      pharmacokinetics, and accumulation was minimal during multiple-dose treatment. 
      Limited efficacy data indicated that treatment with BAY 50-4798 caused at least a 
      transient increase in CD4(+) T cell counts in some recipients, particularly at 
      the early time points. In general, this effect appeared to increase with 
      increasing dose. Bay 50-4798 was generally well tolerated across the dose range 
      tested, but a lack of potent, sustained immunologic activity suggests that 
      further optimization of dose and schedule will be necessary.
FAU - Davey, Richard T
AU  - Davey RT
AD  - National Institutes of Health, National Institute of Allergy and Infectious 
      Disease, Bethesda, MD 20892, USA. rdavey@niaid.nih.gov
FAU - Pertel, Peter E
AU  - Pertel PE
FAU - Benson, Alice
AU  - Benson A
FAU - Cassell, Delanie J
AU  - Cassell DJ
FAU - Gazzard, Brian G
AU  - Gazzard BG
FAU - Holodniy, Mark
AU  - Holodniy M
FAU - Lalezari, Jacob P
AU  - Lalezari JP
FAU - Levy, Yves
AU  - Levy Y
FAU - Mitsuyasu, Ronald T
AU  - Mitsuyasu RT
FAU - Palella, Frank J
AU  - Palella FJ
FAU - Pollard, Richard B
AU  - Pollard RB
FAU - Rajagopalan, Prabhu
AU  - Rajagopalan P
FAU - Saag, Michael S
AU  - Saag MS
FAU - Salata, Robert A
AU  - Salata RA
FAU - Sha, Beverly E
AU  - Sha BE
FAU - Choudhri, Shurjeel
AU  - Choudhri S
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - J Interferon Cytokine Res
JT  - Journal of interferon & cytokine research : the official journal of the 
      International Society for Interferon and Cytokine Research
JID - 9507088
RN  - 0 (Anti-HIV Agents)
RN  - 0 (Cytokines)
RN  - 0 (Interleukin-2)
RN  - 0 (Recombinant Proteins)
RN  - M89N0Q7EQR (aldesleukin)
SB  - IM
MH  - Adult
MH  - Anti-HIV Agents/*administration & dosage/adverse effects/pharmacokinetics
MH  - *Antiretroviral Therapy, Highly Active
MH  - Cytokines/metabolism
MH  - Double-Blind Method
MH  - Female
MH  - HIV Infections/*drug therapy/immunology/metabolism
MH  - Humans
MH  - Injections, Subcutaneous
MH  - Interleukin-2/administration & dosage/adverse effects/agonists/*analogs & 
      derivatives/pharmacokinetics
MH  - Lymphocyte Count
MH  - Male
MH  - Maximum Tolerated Dose
MH  - Middle Aged
MH  - Recombinant Proteins/administration & dosage/adverse effects/pharmacokinetics
EDAT- 2008/02/19 09:00
MHDA- 2008/04/15 09:00
CRDT- 2008/02/19 09:00
PHST- 2008/02/19 09:00 [pubmed]
PHST- 2008/04/15 09:00 [medline]
PHST- 2008/02/19 09:00 [entrez]
AID - 10.1089/jir.2007.0064 [doi]
PST - ppublish
SO  - J Interferon Cytokine Res. 2008 Feb;28(2):89-100. doi: 10.1089/jir.2007.0064.