EFFECTS OF THALIDOMIDE ON HIV-ASSOCIATED WASTING SYNDROME - A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL-TRIAL

Objective: To evaluate the efficacy of thalidomide in treating wasting syndrome in patients with advanced HIV disease, and to assess the eff ects of thalidomide on circulating CD4+ T cells, and on HIV viral burd en in peripheral blood mononuclear cells (PBMC). Design: Randomized, d ouble-blind placebo-controlled clinical trial. Setting: Public tertiar y care hospital in Mexico City. Patients: Twenty-eight adults with adv anced HIV disease being treated with antiretroviral therapy, and who h ad received antiretrovirals for at least 6 months, who did not have an active opportunistic infection, and who had 10% weight loss in the pr evious 6 months. Interventions: Patients received thalidomide (100 mg by mouth, four times daily) or a matching placebo for the duration of the study (12 weeks). Main outcome measures :The main clinical endpoin t for efficacy of thalidomide was weight gain or no progression of was ting. Secondary endpoints were Karnosfsky performance status, CD4+ cel l counts, and HIV viral burden in PBMC. Results: Both groups were comp arable in their baseline status. Therapeutic failure occurred in 10 ou t of 14 patients from the placebo group and in three out of 14 from th e thalidomide group (P = 0.021). Weight gain occurred in one patient o n placebo and in eight given thalidomide. The Karnofsky index was sign ificantly higher by the end of the study in the thalidomide group (P = 0.003). Mild and transient somnolence and erythematous macular skin l esions were significantly more common in the thalidomide group. CD4+ T cell counts and HIV viral burden in PBMC did not change in either gro up. Conclusions: Results suggest that thalidomide not only impeded but also reverted the wasting syndrome, preserving the Karnofsky index in patients with advanced HIV disease. Thalidomide, at the dosage used i n this study, had no effect on peripheral CD4+ T cells nor on HIV vira l burden in PBMC.