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Glaxo’s nucleoside analog 3TC

Executive Summary

Is in two Phase II/III trials in North America involving a total of 645 AIDS patients. One trial involves a comparison of three treatment groups: low dose 3TC with AZT (Burroughs Wellcome's Retrovir) versus high dose 3TC with AZT versus ddC (Roche's Hivid) with AZT in treating HIV-infected, AZT-experienced ( >/= 24 weeks) patients with CD4 cell counts of 100-300/mm. The other study involves a comparison of four arms: 3TC alone, AZT alone, low dose 3TC with AZT and high dose 3TC with AZT in HIV- infected patients, who are AZT naive ( </= 4 weeks) with CD4 cell counts of 200-500/mm. "The Pink Sheet" (Nov. 8, T&G-5) incorrectly described the total number of patients and design of the protocols.

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PS023591

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