Changes in renal function associated with indinavir

Background: Indinavir use is associated with a spectrum of renal and urinar y tract complications including nephrolithiasis, renal colic and pain witho ut recognizable lithiasis, and a picture of crystalluria-dysuria. A frank n ephropathy has not been recognized as part of the spectrum. Methods: A retrospective analysis of 106 HIV-infected individuals receiving indinavir was performed with the purpose of identifying the frequency and risk factors for indinavir-associated nephropathy and urinary complications . individuals receiving ritonavir or nelfinavir served as controls. Results: A sustained elevation of creatinine (> 20%, into abnormal range) w as identified in 20 (18.6%) subjects treated with indinavir but not with ot her protease inhibitors. Creatinine elevation was associated with treatment duration of more than 54 weeks [odds ratio (OR), 7.1; 95% confidence inter val (CI), 1.8-27.7], low baseline body mass index less than or equal to 2 0 kg/m(2) (OR, 4.0; 95% CI, 1.0-16.6), and use of trimethoprim-sulphamethoxa zole (TMP-SMX; OR, 4.6; 95% CI, 1.5-13.8). Lower urinary specific gravity ( P = 0.015), and leukocyturia (P < 0.001) were frequently associated feature s of indinavir nephropathy. No patient developed severe renal impairment an d abnormalities were reversible upon discontinuation of the drug. Complicat ions (renal colic, or pain and dysuria) occurred after a mean of 36 weeks ( 95% CI, 23-48) of indinavir treatment in 13 subjects (12.3%), eight of whom (62%) presented elevated creatinine during follow-up. Only long-term expos ure to TMP-SMX (> 160 weeks) was identified as a potential risk for the occ urrence of a clinical event (OR, 4.7; 95% CI, 1.2-19.2). Conclusions: A crystal nephropathy, characterized by serum creatinine eleva tion, loss of concentrating ability of the kidney, leukocyturia, and renal parenchymal image abnormalities, is a frequent complication of indinavir th erapy. Identification of individuals at risk, particularly those with low b ody mass index or receiving TMP-SMX prophylaxis, may help the decision to i nitiate indinavir or chose an alternative protease inhibitor in order to mi nimize renal and urinary tract adverse events. (C) 1998 Lippincott Williams & Wilkins.