TreatmentUpdate77 - Vol. 7, No. 7; April 1997
Sean Hosein

The American study ACTG 320 has been stopped because preliminary results were "impressive". (Note: as only limited information was released we cannot present a detailed report.) The study enrolled at least 1,156 volunteers (subjects) with an average of 88 CD4+ cells. Before entering the trial, subjects had all used AZT but not protease inhibitors nor had they taken 3TC for more than 1 week. Researchers randomly selected subjects who received one of two combinations:

* triple therapy -- indinavir, 3TC and AZT or ddI * double therapy -- AZT and 3TC

Results

Although some subjects had been in the study for a year, 50% were enrolled for 9.5 months.

* Survival: the number of deaths among subjects on triple therapy (8) was roughly 50% less than among subjects receiving double therapy (18).

* Disease progression: the course of illness grew worse in 33 people on triple therapy compared to 63 people on double therapy, again a difference of about 50%.

These benefits of triple therapy were seen in people with less than 50 CD4+ cells. Apparently the study drugs were "well tolerated" and "there were no major differences in the safety or toxicity of the two regimens."

REFERENCE:

1. Anonymous. SCRIP March 4th 1997, page 16.

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