Safety, Tolerability, and Pharmacokinetic Effects of Thalidomide in Patients Infected with Human Immunodeficiency Virus: AIDS Clinical Trials Group 267 | Zendy

David A. Wohl | Zendy; Francesca Aweeka | Zendy; John L. Schmitz | Zendy; Roger J. Pomerantz | Zendy; Deborah Weng Cherng | Zendy; John Spritzler | Zendy; Lawrence Fox | Zendy; David Simpson | Zendy; Dawn Bell | Zendy; M. K. Holohan | Zendy; Steven Thomas | Zendy; Wayne Robinson | Zendy; Gilla Kaplan | Zendy; Hedy Teppler | Zendy

Open Access

Safety, Tolerability, and Pharmacokinetic Effects of Thalidomide in Patients Infected with Human Immunodeficiency Virus: AIDS Clinical Trials Group 267

Author(s) -

David A. Wohl,

Francesca Aweeka,

John L. Schmitz,

Roger J. Pomerantz,

Deborah Weng Cherng,

John Spritzler,

Lawrence Fox,

David Simpson,

Dawn Bell,

M. K. Holohan,

Steven Thomas,

Wayne Robinson,

Gilla Kaplan,

Hedy Teppler

Publication year - 2002

Publication title -

the journal of infectious diseases

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 2.69

H-Index - 252

eISSN - 1537-6613

pISSN - 0022-1899

DOI - 10.1086/340133

Subject(s) - tolerability , medicine , human immunodeficiency virus (hiv) , clinical trial , sida , pharmacokinetics , virology , thalidomide , immunology , viral disease , adverse effect , pharmacology , multiple myeloma

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/mm(3) 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.

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