TreatmentUpdate 71, Volume 8, No 7; October 1996
Sean Hosein
Doctors in Brazil, Canada and the US have enrolled 490 HIV-infected volunteers for this study. No subject was supposed to have used AZT or protease inhibitors before entering this study. Subjects had between 50 and 500 CD4+ cells and received either AZT 600 mg/day, or indinavir 800 mg/8 hours or a combination of both drugs.
Results -- CD4+ cell counts
At the 6th month of the study, researchers found that subjects in the following groups had increased numbers of CD4+ cells compared to their pre-study levels:
* AZT - 28 cells
* indinavir - 91 cells
* combination - 85 cells
The larger increase in the in CD4+ cell counts in the indinavir group compared to the AZT group was [statistically] significant. This means that use of indinavir was responsible for the greatest increase - not luck or chance.
Results -- amount of virus
When technicians measured changes in the amount of HIV in the blood they found the following changes:
* AZT group -- a slight increase
* indinavir -- a decrease in viral load to 1/8 times the pre-study level
* combination -- a decrease to about 1 /11th the pre-study level
The greater decrease in viral load in subjects receiving indinavir (alone or in combination) compared to that seen in the subjects receiving AZT was [statistically] significant, that is; not likely due to chance alone.
Summary
Use of indinavir alone or together with AZT caused an increase of at least 80 CD4+ cells and reduced production of HIV to 1/11th of its pre-study level.
REFERENCES:
1. Leavitt R, Massari F, Nessly M, et al . Antiviral activity of indinavir plus AZT compared to indinavir or AZT alone in antiretroviral naive patients. Abstract I109.
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