Virological and Immunological Effects of Combination Antiretroviral Therapy with Zidovudine, Lamivudine, and Indinavir during Primary Human Immunodeficiency Virus Type 1 Infection

Smith, Don ; Berrey, M. Michelle ; Robertson, Michael ; Mehrotra, Devan ; Markowitz, Martin ; Perrin, Luc ; Clumeck, Nathan ; Lazzarin, Adriano ; Burckhardt, Beat ; Weber, Rainer ; Corey, Lawrence ; Cooper, David A.

In: The Journal of Infectious Diseases, 2000, vol. 182, no. 3, p. 950-954

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    Forty-seven patients presenting with primary human immunodeficiency virus (HIV) infection were treated with zidovudine 200 mg 3 times a day, lamivudine 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 log10 copies/mL, the proportions 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 weeks, 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 log10 copies/mL at weeks 8 and 52, respectively. CD4 cell counts increased, from a mean of 546 cells/mm3, by 142 cells/mm3 at week 24 and by 210 cells/mm3 at week 52. Three patients discontinued the study because of drug-related toxicity. Six (12.8%) patients had adverse experiences associated with nephrolithiasis. Combination therapy with zidovudine, lamivudine, and indinavir during primary HIV infection results in a profound and sustained reduction in virus load with concurrent recovery of the CD4 cell population