Objective: To study the immunologic effects of recombinant human growth hormone (rhGH), recombinant human insulin-like growth factor type 1 (rhIGF-1), or the combination, in patients with moderately advanced HIV infection.
Design: Randomized but not blinded trial.
Setting: Government medical research center.
Purpose: A phase I/II study of oral all-trans-retinoic acid (ATRA; tretinoin), administered every other week alone and then in combination with interferon (IFN) alfa-2a, was undertaken to evaluate the activity, toxicity, and pharmacokinetics of this regimen in patients with human immunodeficiency virus (HIV)-associated Kaposi's sarcoma (KS).
Patients And Methods: Thirteen patients with HIV-associated KS, eight of whom had more than 100 CD4 cells/microL, were entered. The protocol initially called for patients to receive 150 mg/m2/d of ATRA every other week.
Purpose: Administration of all-trans-retinoic acid (ATRA) on a continuous daily schedule results in a rapid and sustained decrease in plasma drug concentrations. This pharmacokinetic study was performed to determine if administration of ATRA on an intermittent schedule could overcome the rapid decrease in plasma drug concentration and provide repetitive periods of higher plasma drug exposure.
Materials And Methods: ATRA was administered on repetitive cycles of 7 consecutive days of drug followed by 7 days without drug.
In a cadaver-derived skeletal collection of 1,384 thoracolumbar spinal columns, 103 (7.4%) individuals with vertebral changes of Scheuermann's kyphosis were identified. Anterior extension of the vertebral specimens was noted in 94% of affected specimens.
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