The effect of thalidomide on the pathogenesis of human immunodeficiency virus type 1 and M. tuberculosis infection

J Acquir Immune Defic Syndr Hum Retrovirol. 1996 Mar 1;11(3):247-57. doi: 10.1097/00042560-199603010-00005.


Tumor necrosis factor alpha (TNF-alpha), a cytokine produced during the host defense against infection, is associated with fevers, weakness, and progressive weight loss. Thalidomide inhibits the synthesis of TNF-alpha both in vitro and in vivo and may have clinical usefulness. We therefore initiated a pilot study of thalidomide treatment in patients with human immunodeficiency virus type 1 (HIV-1)-associated wasting with or without concomitant infection with tuberculosis. Thirty-nine patients were randomly allocated to treatment with either thalidomide or placebo in a double-blind manner for 21 days. Thirty-two patients completed the study. In patients with concomitant HIV-1 and tuberculosis infections, thalidomide therapy was associated with a reduction in both plasma TNF-alpha levels and HIV-1 levels. No significant reduction in either TNF-alpha or HIV- 1 levels was observed in patients with HIV-1 infection only. During the study period, patients receiving thalidomide treatment (n=16) showed a significant weight gain (mean +/- SEM: 6.5 +/- 1.2%; p<0.02) relative to placebo-treated patients (n=16). Patients with simultaneous HIV-1 and tuberculosis infections experienced a higher mean weight gain during thalidomide treatment than the group of patients with HIV-1 infection only. The results of this pilot study suggest that thalidomide may have a clinical role in enhancing weight gain and possibly reducing TNF-alpha and HIV-1 levels in patients with HIV-1 and concomitant mycobacterial infections.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Body Weight / drug effects
  • CD4 Lymphocyte Count
  • Double-Blind Method
  • HIV Infections / complications
  • HIV Infections / drug therapy*
  • HIV Infections / etiology
  • HIV-1 / drug effects*
  • Humans
  • Immunosuppressive Agents / adverse effects
  • Immunosuppressive Agents / therapeutic use*
  • Male
  • Middle Aged
  • Pilot Projects
  • Placebos
  • Thalidomide / adverse effects
  • Thalidomide / therapeutic use*
  • Tuberculosis, Pulmonary / complications
  • Tuberculosis, Pulmonary / drug therapy*
  • Tuberculosis, Pulmonary / etiology
  • Tumor Necrosis Factor-alpha / analysis


  • Immunosuppressive Agents
  • Placebos
  • Tumor Necrosis Factor-alpha
  • Thalidomide