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A phase I/II study of the safety and activity of a microsphere formulation of KNI-272 in patients with HIV-1 infection.

Abstract
Eighteen patients with symptomatic HIV disease were enrolled into a phase I/II study of a microsphere formulation of the HIV protease inhibitor KNI-272, with doses escalated up to a maximum dose of 60 mg/kg/day. One patient developed reversible elevation in hepatic transaminase. The plasma half-life of the drug was very short, varying between 0.25 and 1.1 h. No consistent effect on plasma HIV RNA levels or CD4(+) lymphocyte counts was seen.
AuthorsD R Churchill, P M Slade, M Youle, B G Gazzard, J N Weber
JournalThe Journal of antimicrobial chemotherapy (J Antimicrob Chemother) Vol. 47 Issue 3 Pg. 353-5 (Mar 2001) ISSN: 0305-7453 [Print] England
PMID11222570 (Publication Type: Clinical Trial, Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article)
Chemical References
  • Anti-HIV Agents
  • Oligopeptides
  • RNA, Viral
  • Alanine Transaminase
  • kynostatin 272
Topics
  • Adult
  • Alanine Transaminase (drug effects, metabolism)
  • Anti-HIV Agents (adverse effects, pharmacokinetics, therapeutic use)
  • Area Under Curve
  • CD4 Lymphocyte Count
  • CD4-Positive T-Lymphocytes (cytology, drug effects)
  • Cohort Studies
  • Dose-Response Relationship, Drug
  • HIV Infections (drug therapy)
  • HIV-1 (drug effects, genetics)
  • Humans
  • Male
  • Microspheres
  • Middle Aged
  • Oligopeptides (adverse effects, pharmacokinetics, therapeutic use)
  • Patient Dropouts
  • RNA, Viral (blood, drug effects)
  • Treatment Outcome

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