TreatmentUpdate 70, Volume 8, No 6; September, 1996
Sean Hosein
In this study researchers compared the effects of different regimens:
* Indinavir alone
* AZT and 3TC
The drugs were taken in their standard doses: AZT 600 mg/day, 3TC 300 mg/day and indinavir 2.4 grams/day. Researchers assigned subjects at random to each group. All 91 subjects were HIV-infected adults (15 female, 76 male), at least half of whom had a CD4+ cell count of 144 cells. No subject was supposed to have used a protease inhibitor before entering this study. Neither doctors nor subjects were supposed to know which combination of drugs was used.
Results -- HIV
Those subjects receiving the triple combination had a dramatic reduction in the amount of HIV in their blood, averaging about 1/100 th their pre-study level, a reduction was sustained for 44 weeks. Subjects receiving AZT and 3TC had the amount of HIV in their blood fall by 50%. This reduction was sustained for the rest of the study.
Results -- CD4+ cell counts
Subjects who received AZT and 3TC had an average increase of 40 CD4+ cells compared with their pre-study levels. Those subjects receiving indinavir alone or in combination had their CD4+ cell counts rise by 100 cells. This increase was maintained for 9 months. Readers should note that as the trial progressed, more subjects began to leave.
Toxicity
Four subjects in the AZT/3TC group and 2 others developed:
* low levels of certain white blood cells called neutrophils.
Twenty-two produced higher-than-normal levels of :
* bilirubin.
Eight subjects receiving indinavir and one on AZT/3TC developed
* kidney stones.
REFERENCES:
1. Gulick RM, Mellors J, Havlir D, et al. Potent and sustained antiretroviral activity of indinavir, zidovudine and lamivudine. Th.B.931
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