TY - JOUR
T1 - Safety, tolerability, and pharmacokinetic effects of thalidomide in patients infected with human immunodeficiency virus
T2 - AIDS Clinical Trials Group 267
AU - Wohl, David A.
AU - Aweeka, Francesca T.
AU - Schmitz, John
AU - Pomerantz, Roger
AU - Cherng, Deborah Weng
AU - Spritzler, John
AU - Fox, Lawrence
AU - Simpson, David
AU - Bell, Dawn
AU - Holohan, M. K.
AU - Thomas, Steven
AU - Robinson, Wayne
AU - Kaplan, Gilla
AU - Teppler, Hedy
PY - 2002/5/1
Y1 - 2002/5/1
N2 - Thalidomide is used to treat human immunodeficiency virus (HIV)-associated conditions, including aphthous ulcers and wasting syndrome. The safety, tolerability, and pharmacokinetics of a formulation of thalidomide with improved bioavailability in HIV-infected persons was examined in a placebo-controlled, dose-escalating phase 1 study. Subjects with CD4 cell counts of 200-500 cells/mm3 were enrolled and randomized 3:1 in groups of 12 to receive 50, 100, or 150 mg of thalidomide or matching placebo. Two subjects who received 150 mg of drug and 2 subjects assigned placebo experienced dose-limiting toxicity. Concentrations of thalidomide in the blood increased with escalating dose, but the time to maximum concentration and clearance did not differ across dose cohorts. Previous suggestions of autoinduction of drug metabolism were not confirmed by this study. At the doses studied, thalidomide was tolerated well and had linear pharmacokinetics.
AB - Thalidomide is used to treat human immunodeficiency virus (HIV)-associated conditions, including aphthous ulcers and wasting syndrome. The safety, tolerability, and pharmacokinetics of a formulation of thalidomide with improved bioavailability in HIV-infected persons was examined in a placebo-controlled, dose-escalating phase 1 study. Subjects with CD4 cell counts of 200-500 cells/mm3 were enrolled and randomized 3:1 in groups of 12 to receive 50, 100, or 150 mg of thalidomide or matching placebo. Two subjects who received 150 mg of drug and 2 subjects assigned placebo experienced dose-limiting toxicity. Concentrations of thalidomide in the blood increased with escalating dose, but the time to maximum concentration and clearance did not differ across dose cohorts. Previous suggestions of autoinduction of drug metabolism were not confirmed by this study. At the doses studied, thalidomide was tolerated well and had linear pharmacokinetics.
UR - http://www.scopus.com/inward/record.url?scp=0036569235&partnerID=8YFLogxK
U2 - 10.1086/340133
DO - 10.1086/340133
M3 - Article
C2 - 12001058
AN - SCOPUS:0036569235
SN - 0022-1899
VL - 185
SP - 1359
EP - 1363
JO - Journal of Infectious Diseases
JF - Journal of Infectious Diseases
IS - 9
ER -