Document 2801 DOCN M94A2801 TI Treatment with thalidomide in AIDS patients. DT 9412 AU Klausner JD; Makonkawkeyoon S; Akarasewi P; Kasinrerk W; Nakata K; Kaplan G; NYU Med Cntr. Dept of Med., NY. SO Int Conf AIDS. 1994 Aug 7-12;10(1):221 (abstract no. PB0312). Unique Identifier : AIDSLINE ICA10/94369774 AB OBJECTIVES: To demonstrate that thalidomide reduces the toxic manifestations of tumor necrosis factor (TNF) and decreases HIV-1 viral burden in patients with AIDS. METHODS: In a randomized, double-blind, prospective study, 41 male patients with AIDS and 6 months of weight loss were given 300 mg of thalidomide or placebo nightly for 21 days. Baseline and serial weekly symptom scores, body weights, CD 4 counts and plasma for HIV-1 titers were obtained. RESULTS: Treated patients (n = 16, mean age 32, 48% with tuberculosis (TB), median CD4 count = 34) reported an increased appetite and gained an average of 4.5% in body weight versus 0.9% (P < 0.01) in controls (n = 16, mean age 32, 45% with TB, median CD4 count = 36). Six (29%) patients on thalidomide developed a drug rash. CD4 counts did not change with therapy. P24 antigen titers were measurable in 5 patients and decreased in 3 patients on thalidomide. DISCUSSION AND CONCLUSIONS: Thalidomide increased appetite and produced weight gain in AIDS patients with wasting. There was no significant adverse effect on immunosuppression and its effect on HIV-1 viral burden is forthcoming. DE Acquired Immunodeficiency Syndrome/COMPLICATIONS/*DRUG THERAPY/ MICROBIOLOGY Adult Appetite/DRUG EFFECTS Double-Blind Method Human HIV-1/ISOLATION & PURIF Male Prospective Studies Thalidomide/PHARMACOLOGY/*THERAPEUTIC USE Treatment Outcome Tuberculosis/COMPLICATIONS Tumor Necrosis Factor/*ANALYSIS Weight Gain/DRUG EFFECTS CLINICAL TRIAL MEETING ABSTRACT RANDOMIZED CONTROLLED TRIAL SOURCE: National Library of Medicine. NOTICE: This material may be protected by Copyright Law (Title 17, U.S.Code).