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- Title
2',3'-didehydro-3'-deoxythymidine (d4T) in patients with AIDS or AIDS-related complex: a phase I trial.
- Authors
Browne, Marcia J.; Mayer, Kenneth H.; Chafee, Stephanie B. D.; Dudley, Michael N.; Posner, Marshall R.; Steinberg, Seth M.; Graham, Kathleen K.; Geletko, Sandra M.; Zinner, Stephen H.; Denman, Sandra L.; Dunkle, Lisa M.; Kaul, Sanjeev; McLaren, Colin; Skowron, Gail; Kouttab, Nicola M.; Kennedy, Theresa A.; Weitberg, Alan B.; Curt, Gregory A.; Browne, M J; Mayer, K H
- 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 levelswas 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 levelshad 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.
- Publication
Journal of Infectious Diseases, 1993, Vol 167, Issue 1, p21
- ISSN
0022-1899
- Publication type
journal article
- DOI
10.1093/infdis/167.1.21