PMID: 9430254Jan 16, 1998Paper

A double-blind placebo-controlled phase II trial of thalidomide in asymptomatic HIV-positive patients: clinical tolerance and effect on activation markers and cytokines

AIDS Research and Human Retroviruses
J B MarriottA G Dalgleish

Abstract

A randomized double-blind, placebo-controlled study was performed to determine the safety, efficacy, and effect of thalidomide on a variety of immunological and biochemical parameters in asymptomatic human immunodeficiency virus (HIV)-positive patients. Nineteen male patients with elevated markers of immune activation and CD4 cell counts above 400/mm3 were randomized to either placebo or thalidomide at 100 mg/day for 24 weeks. However, only 3 (of 10) patients receiving thalidomide completed all 24 weeks compared to 6 (of 9) patients receiving placebo. This was mainly due to fatigue (somnolence is a recognized side effect), although this was also seen to a lesser extent in the placebo group and so may not be drug attributable. No significant changes in CD4/CD8 count, activation markers, TNF-alpha, or TNFR1 were observed. However, a nonsignificant trend toward inhibition of mitogen-induced TNF-alpha production was observed in the thalidomide arm. The lack of systemic effect and the lower tolerance of thalidomide (at this dose) in asymptomatic patients highlights the need for pharmacokinetic analysis to address possible absorption problems and the need for more potent and less toxic TNF-alpha inhibitors to be developed for use in ...Continue Reading

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Citations

Nov 24, 1999·Immunology Today·J B MarriottA G Dalgleish
Feb 18, 2003·Journal of Internal Medicine·R P Baughman, J P Lynch
Aug 10, 1999·Molecular Pathology : MP·K R BaumforthP G Murray
Jan 25, 2005·American Journal of Clinical Dermatology·Robert P Baughman, Elyse E Lower
Jan 24, 2014·Mediators of Inflammation·Amit KumarGeorges Herbein
May 19, 2012·Seminars in Oncology·Wai M Liu, Angus G Dalgleish
Jan 30, 1999·Journal of Obstetric, Gynecologic, and Neonatal Nursing : JOGNN·C A Cahill
Oct 23, 2010·Journal of Pain and Symptom Management·Eric E PrommerAndrew Wilcock
Sep 12, 2007·Bioorganic & Medicinal Chemistry Letters·Esperanza J Carcache de-BlancoPui-Kai Li
Jan 1, 1997·Tubercle and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease·G VanhamJ J Ellner
Jul 13, 2002·Chest·Robert P BaughmanElyse E Lower
Sep 22, 2001·The American Journal of Hospice & Palliative Care·M P Davis, E D Dickerson
Jun 15, 2020·Current HIV/AIDS Reports·Aaren KettelhutNicholas T Funderburg

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