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 effects of thalidomide on circulating CD4+ T cells, and on HIV viral burden in peripheral blood mononuclear cells (PBMC).


METHODS
Randomized, double-blind placebo-controlled clinical trial.


METHODS
Public tertiary care hospital in Mexico City.


METHODS
Twenty-eight adults with advanced HIV disease being treated with antiretroviral therapy, and who had received antiretrovirals for at least 6 months, who did not have an active opportunistic infection, and who had 10% weight loss in the previous 6 months.


METHODS
Patients received thalidomide (100 mg by mouth, four times daily) or a matching placebo for the duration of the study (12 weeks).


METHODS
The main clinical endpoint for efficacy of thalidomide was weight gain or no progression of wasting. Secondary endpoints were Karnofsky performance status, CD4+ cell counts, and HIV viral burden in PBMC.


RESULTS
Both groups were comparable in their baseline status. Therapeutic failure occurred in 10 out of 14 patients from the placebo group and in three out of 14 from the thalidomide group (P = 0.021). Weight gain occurred in one patient on placebo and in eight given thalidomide. The Karnofsky index was significantly higher by the end of the study in the thalidomide group (P = 0.003). Mild and transient somnolence and erythematous macular skin lesions were significantly more common in the thalidomide group. CD4+ T cell counts and HIV viral burden in PBMC did not change in either group.


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 in this study, had no effect on peripheral CD4+ T cells nor on HIV viral burden in PBMC.
Reyes-Terán
G
G
Department of Infectious Diseases, Instituto Nacional de la Nutrición Salvador Zubirán, Tlalpan, México, D.F., México.
Sierra-Madero
J G
JG
Martínez del Cerro
V
V
Arroyo-Figueroa
H
H
Pasquetti
A
A
Calva
J J
JJ
Ruiz-Palacios
G M
GM
D000328:Adult; D018791:CD4 Lymphocyte Count; D002478:Cells, Cultured; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D006801:Humans; D017567:Karnofsky Performance Status; D007963:Leukocytes, Mononuclear / Q000166:cytology / Q000276:immunology / Q000821:virology; D008297:Male; D013792:Thalidomide / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D019282:Wasting Syndrome / Q000150:complications / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D015431:Weight Loss
D013792:Thalidomide