Methods
Myopathy occurs in association with human immunodeficiency virus type 1 (HIV-1) infection, 2,8,17,19 and AIDS Clinical Trials Group (ACTG) Protocol 016 was designed to explore the safety and efficacy of ZDV as toxicity of the antiretroviral agent zidovudine (ZDV, AZT). 3,6,9,15 Retrospective series have reported in patients with mildly symptomatic HIV-1 infection.
The details of the study design have been previously variable frequencies of the HIV and ZDV myopathies, 6,9,11,18,21 due in part to different definitions of published. 7 Between August 1987 and May 1989, subjects were recruited from 29 AIDS Clinical Trials myopathy. Studies which base the definition of myopathy on the presence of myalgia or elevated creatine Units from across the United States. The mean pretreatment CD4 T-lymphocyte count was 200-800 kinase (CK) levels show higher frequencies than those which employ more rigorous criteria, including cells/mm 3 . Patients had repeated documentation of history and examination which addressed myalgia objective muscle weakness, electrophysiological studies, and muscle biopsy. 14,18 Emphasis has been placed and limb strength, the occurrence of myopathy, or myositis. CK was obtained at most centers within 28 on the potential for ZDV therapy to elevate serum CK levels, but there is no reliable information on months of study onset, and by study termination CK was obtained on all subjects. how often CK abnormalities reflect clinical muscle disease. The percentage of patients with myopathies ZDV-treated and placebo groups were compared for the presence of myalgia, limb weakness, CK levels, that improve following ZDV withdrawal has varied from 18 to 100%. 6,9,11,13,15,18 These observations have and reports of myopathy or myositis. Due to significant differences in primary outcome during a created management difficulties for clinicians faced with patients who develop an elevation in CK or myal-planned interim analysis, the study was unblinded and placebo-treated patients were offered the option gia while on ZDV therapy. This study reports an analysis of data relevant to myopathy in a large placebo-of receiving ZDV. We did not analyze patient data following this unblinding and continued treatment controlled ZDV study. of all patients with ZDV (August 3, 1989). CK abnormalities were classified as follows based on the multiple of the upper limit of normal (ULN) for the particular laboratory: grade 1: 1.1-2.0; grade 2: 2.1-4.0; grade 3: 4.1-6.0; grade 4: у 6.1. Myalgia and limb weakness were graded 1 (minimal) to 4