| Literature DB >> 8093363 |
M J Browne1, K H Mayer, S B Chafee, M N Dudley, M R Posner, S M Steinberg, K K Graham, S M Geletko, S H Zinner, S L Denman.
Abstract
2',3'-didehydro-3'-deoxythymidine (d4T) is a pyrimidine analogue and inhibitor of reverse transcriptase with potent in vitro activity against human immunodeficiency virus (HIV). A phase I trial of d4T was conducted in 41 HIV-infected patients, 12 with AIDS and 29 with AIDS-related complex (ARC). Thirty-six patients were evaluatable. The maximum tolerated dose was 2 mg/kg/day. The dose-limiting toxicity was sensory peripheral neuropathy, which occurred in 20 patients (55%). Four patients (11%) developed hepatotoxicity. Five (14%) developed anemia requiring a transfusion but not discontinuation of drug. The mean +/- SE plasma elimination half-life at all dose levels was 1.2 +/- 0.09 h. Increased or stable absolute CD4 counts were seen in most patients. The majority of patients with detectable serum p24 antigen levels had a persistent decrease by 6 months. d4T is a promising drug for patients with AIDS or ARC. This clinical trial is continuing to determine the minimal effective dose.Entities:
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Year: 1993 PMID： 8093363 DOI： 10.1093/infdis/167.1.21
Source DB: PubMed Journal: J Infect Dis ISSN： 0022-1899 Impact factor: 5.226