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Gail Skowron, Biologic Effects And Safety Of Stavudine: Overview Of Phase I And Ii Clinical Trials, The Journal of Infectious Diseases, Volume 171, Issue Supplement_2, March 1995, Pages S113–S117, https://doi.org/10.1093/infdis/171.Supplement_2.S113
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Abstract
Data on the biologic effects and safety of stavudine in patients with AIDS and AIDS-related complex represent results of two phase I trials (n = 84), another phase I study of patients with hematologic intolerance to zidovudine (n = 23), and a phase II trial (n = 152). The daily doses of stavudine ranged from 0.1 to 12.0 rug/kg. Increases in CD4 cell count, declines in serum p24 antigen, and weight gain were all related to the dose of stavudine. Doses of <2 rug/kg/day (n = 216) were well-tolerated, with a median duration of therapy of > 48 weeks in the phase I studies and >79 weeks in the phase II study. The predominant dose-limiting toxicity was peripheral neuropathy, which was related to both the dose and duration oftreatment with stavudine. Elevations ofliver enzymes were seen in some patients but appeared to be related to underlying disease rather than treatment. There was no evidence of dose-related hematologic toxicity.
- peripheral neuropathy
- acquired immunodeficiency syndrome
- aids related complex
- cd4 count determination procedure
- phase 1 clinical trials
- phase 2 clinical trials
- safety
- stavudine
- weight gain
- zidovudine
- enzymes
- hematology
- toxic effect
- hiv p24 antigen test
- hematotoxicity
- duration of treatment
- resource utilization groups