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

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...

Full description

Saved in:
Bibliographic Details
Published in:Journal of antimicrobial chemotherapy 2001-03, Vol.47 (3), p.353-355
Main Authors: Churchill, D. R., Slade, P. M., Youle, M., Gazzard, B. G., Weber, J. N.
Format: Article
Language:English
Subjects:
Adult
Alanine Transaminase - drug effects
Alanine Transaminase - metabolism
Anti-HIV Agents - adverse effects
Anti-HIV Agents - pharmacokinetics
Anti-HIV Agents - therapeutic use
Antibiotics. Antiinfectious agents. Antiparasitic agents
Antiviral agents
Area Under Curve
Biological and medical sciences
CD4 Lymphocyte Count
CD4-Positive T-Lymphocytes - cytology
CD4-Positive T-Lymphocytes - drug effects
Cohort Studies
Dose-Response Relationship, Drug
HIV Infections - drug therapy
HIV-1 - drug effects
HIV-1 - genetics
Humans
Male
Medical sciences
Microspheres
Middle Aged
Oligopeptides - adverse effects
Oligopeptides - pharmacokinetics
Oligopeptides - therapeutic use
Patient Dropouts
Pharmacology. Drug treatments
RNA, Viral - blood
RNA, Viral - drug effects
Treatment Outcome
Citations: Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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.
ISSN:0305-7453
1460-2091
1460-2091
DOI:10.1093/jac/47.3.353