Virological and immunological effects of combination antiretroviral therapy with zidovudine, lamivudine, and indinavir during primary human immunodeficiency virus type 1 infection

Forty-seven patients presenting with primary human immunodeficiency virus ( HIV) infection were treated with zidovudine 200 mg 3 times a day, lamivudin e 150 mg 2 times a day, and indinavir 800 mg 3 times a day for 1 year. From a mean pretreatment viral RNA level of 4.93 log(10) copies/mL, the proport ions of patients having <500 copies/mL at 24 and 52 weeks were 92.0% and 89 .2%, respectively. For the 35 patients with data available at 24 and 52 wee ks, the corresponding proportions for the <50 copies/mL analysis were 86.6% and 79.3%, respectively. The change in virus load was -2.19 and -2.41 log( 10) copies/mL at weeks 8 and 52, respectively. CD4 cell counts increased, f rom a mean of 546 cells/mm(3), by 142 cells/mm(3) at week 24 and by 210 cel ls/mm(3) at week 52. Three patients discontinued the study because of drug- related toxicity. Six (12.8%) patients had adverse experiences associated w ith nephrolithiasis. Combination therapy with zidovudine, lamivudine, and i ndinavir during primary HIV infection results in a profound and sustained r eduction in virus Load with concurrent recovery of the CD4 cell population.