In this double-blind study, 97 patients who had received treatment zidovudine for at least six months with HIV, and 50 to 400 CD4 cells per cubic millimeter, and at least 20,000 HIV RNA copies per milliliter had a randomly were assigned to three treatments for 52 weeks: 800 mg
indinavir every eight hours; 200 mg zidovudine 150 mg every eight hours with lamivudine twice daily in combination; or all three drugs. Patients had to monitor the occurrence of adverse events and changes in viral load and CD4 cell count.
RESULTS:
The decrease in HIV RNA during the first 24 weeks were higher in the group of three drugs in other groups (p <0.001 for each comparison). RNA levels dropped to less than 500 copies per milliliter at week 24 in 28 of 31 patients in the group of three drugs (90 percent), 12 of 28 patients in the indinavir group (43 percent), and none of the 30 patients in the zidovudine group -lamivudine. Increasing the number of CD4 cells during the first 24 weeks was higher in the two groups receiving indinavir than in the zidovudine-lamivudine group (P <or = 0.01 for each comparison). Changes in viral load and CD4 count remained until 52 weeks. All doses were generally well tolerated.
CONCLUSION:
In most patients with HIV infection with antiretroviral therapy before, the combination of indinavir, zidovudine, lamivudine, and reduced levels of HIV RNA to less than 500 copies per milliliter for as long as one year.
