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Antiretroviral therapy with stavudine (d4T) in patients (pts) who have failed or are intolerant to AZT and ddI.
Dzekov C; Cone L; Hastie M; Pena K; Espinoza G; Eisenhower Medical
December 30, 1995
Natl Conf Hum Retroviruses Relat Infect (1st). 1993 Dec 12-16;:130.

Efficacy and safety of d4T was studied in 36 pts who failed or were intolerant to AZT and DDI, weighed greater than 60 kg. 2 doses, 15 (dose A) and 30 mg (dose B) b.i.d. were given. All pts were ambulatory, with less than 300 CD4+, 5 pts had elevated P24 antigen at baseline and over half had experienced AIDS-related Kaposi's sarcoma or opportunistic infections. 7 pts were excluded from analysis due to protocol violation or being on study less than 1 month. 23 pts were randomized to dose A and 6 to dose B. Mean duration of therapy is 110 days. 13 of 23 with dose A showed a rise in CD4+ cells over baseline after a mean of 60 days which persists at 90 days. 10 pts had a fall in CD4+ cells from baseline and 3 were unchanged. P24 antigen remained unchanged. With dose B all 6 pts showed a rise in CD4+ cells at 1 month of starting d4T but no change in P24 antigen. 3 pts in this group died of AIDS. 4 pts were taken off study due to drug associated neuropathy (2), pancreatitis (1) & diabetes mellitus (1). We conclude from these studies that d4T is an effective and safe antiretroviral agent.

Acyclovir/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE Comparative Study Drug Therapy, Combination Human HIV Core Protein p24/*BLOOD Longitudinal Studies Zidovudine/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE ABSTRACT