Objective: To evaluate specific urological abnormalities in patients treate
d with the protease inhibitor indinavir. Methods: A series of 155 consecuti
ve human immunodeficiency virus-positive patients were treated with indinav
ir 800 mg p.o. three times a day. Of these, 14 (9%) treated for 1-321 (aver
age 110) days experienced severe flank pain and were subjected to clinical
and laboratory examinations. Results: Abdominal X-ray was consistently nega
tive for stones. Ultrasonography showed upper-tract dilatation in 12 patien
ts. Intravenous urography showed obstruction above a radiolucent obstacle i
n 7 patients; in 2 cases, there was a marked delay in urine excretion on th
e obstructed side. The mean urine pH was 6. Urine culture was negative. Ser
um uric acid, phosphorus, and calcium levels were normal. In 8 patients the
re was slight renal insufficiency, and 4 patients required ureteral stentin
g. In all cases, hyperhydration and oral analgesia led to a favorable outco
me. In 3 patients, chemical analysis of the stone demonstrated monohydrate
indinavir crystals. Conclusions: In our experience, indinavir therapy is as
sociated with urolithiasis in 9% of the cases. Hydration, analgesia, and ac
idification of the urine usually lead to a favorable clinical outcome. Prop
hylactic hydration and acidification of the urine are extremely important.