title: Thalidomide for the treatment of AIDS-associated wasting.
abstract: A double-blind, placebo-controlled trial of efficacy and safety of thalidomide in AIDS-associated wasting was carried out. Ninety-nine of 103 male patients had at least one on-study measurement (intent-to-treat [ITT] cohort). Patients were randomized to thalidomide at 100 mg/day (T100) or 200 mg/day (T200), or placebo for 8 weeks. By ITT analysis, the mean change in body weight of the placebo, T100, and T200 treatment groups was 0.3 kg (0.4%), 2.0 kg (3.0%), and 0.9 kg (1.4%), respectively (p = 0.021 for T100 versus placebo; p = 0.53 for T200 versus placebo). Of the 64 patients who completed the 8 weeks of study treatment, significant weight gain was observed in both the T100 group (2.2 kg, [33%]; p = 0.008 versus placebo) and the T200 group (1.5 kg [2.5%]; p = 0.019 versus placebo). Approximately half the weight gain was fat-free mass (bioimpedance analysis). Patients in the T100 or T200 groups had no significant change in CD4+ cell counts, neutrophil counts, or TNF-alpha levels, compared with placebo. HIV viral load measured as log10 copies/ml decreased by a median of 0.07 in the placebo group, and increased by a median of 0.29 (T100 group) and 0.23 (T200 group) (p = 0.024 andp = 0.018 versus placebo, respectively). Thalidomide therapy was associated with mild to moderate rashes and fevers, but not peripheral neuropathy. Although the anabolic benefits of high-dose thalidomide are limited by drug intolerance, 8 weeks of low-dose thalidomide results in significant weight gain in patients with AIDS-associated wasting.
authors.affiliation: Laboratory of Cellular Physiology and Immunology, Rockefeller University, New York, New York 10021, USA. kaplang@rockvax.rockefeller.edu
authors.forename: G
authors.initials: G
authors.lastname: Kaplan
authors.forename: S
authors.initials: S
authors.lastname: Thomas
authors.forename: D S
authors.initials: DS
authors.lastname: Fierer
authors.forename: K
authors.initials: K
authors.lastname: Mulligan
authors.forename: P A
authors.initials: PA
authors.lastname: Haslett
authors.forename: W J
authors.initials: WJ
authors.lastname: Fessel
authors.forename: L G
authors.initials: LG
authors.lastname: Smith
authors.forename: K A
authors.initials: KA
authors.lastname: Kook
authors.forename: D
authors.initials: D
authors.lastname: Stirling
authors.forename: M
authors.initials: M
authors.lastname: Schambelan
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D001823:Body Composition; D001835:Body Weight; D018791:CD4 Lymphocyte Count; D004311:Double-Blind Method; D002149:Energy Intake; D005260:Female; D019247:HIV Wasting Syndrome / Q000188:drug therapy*; D015497:HIV-1 / Q000302:isolation & purification; D006801:Humans; D008297:Male; D008875:Middle Aged; D013792:Thalidomide / Q000627:therapeutic use*; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D013792:Thalidomide