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Being Alive
MEDICAL UPDATE: D4T Phase I Trials
Mark Katz, MD and reported by Jim Stoecker
April 5, 1993
Being Alive 1993 Apr 5: 13

The Journal of Infectious Diseases has published results of a Phase I trial of D4T. In reviewing side effects in the original 41 patients, researchers found that peripheral neuropathy was quite common once the dosage was raised to more than 4 mg per kg of body weight. In dose levels between .5 and 1 mg/kg, however, occurrence of neuropathy was minimal. This lower dosage is what is being used in the current expanded access program for D4T. So this is good news for those who are intolerant of AZT or for whom AZT and ddI failed. Such people can pursue expanded access of D4T (call 1.800.842.8036 for information) without undue concern about peripheral neuropathy.

The study results also noted that, for the 16 patients who received D4T for 24 weeks, median T cell count rose from 189 to 390. Although Phase I trials are dosage escalating studies and are not meant to measure efficacy, this CD4 elevation is very encouraging. We need further studies to determine whether D4T has definite advantages as an antiviral. 

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