A double-blind, placebo-controlled trial of thymostimulin in symptomatic HIV-infected patients.
The potential therapeutic efficacy of the thymic hormone preparation, thymostimulin (TP1), in HIV infection has been studied in a multi-institutional, randomized, double-blind, placebo-controlled trial. Fifty evaluable patients with advanced AIDS-related complex (ARC) were injected with TP1 or placebo twice weekly for 6 months after 2 weeks of daily injections. The primary endpoint, progression to AIDS, was reached in nine TP1- and 11 placebo-treated subjects after 1 year. CD4 cell numbers were not affected by administration of the study drug. No toxicity was associated with TP1 treatment. We conclude that TP1 is ineffective in altering the progress of HIV disease in patients with advanced ARC.
Beall
G
G
Department of Medicine, Harbor-UCLA Medical Center, Torrance.
Kruger
S
S
Morales
F
F
Imagawa
D
D
Goldsmith
J A
JA
Fisher
D
D
Steinberg
J
J
Phair
J
J
Whaling
S
S
Bitran
J
J
D000386:AIDS-Related Complex / Q000097:blood / Q000188:drug therapy*; D000276:Adjuvants, Immunologic / Q000627:therapeutic use; D000328:Adult; D015496:CD4-Positive T-Lymphocytes / Q000187:drug effects; D004311:Double-Blind Method; D006801:Humans; D007958:Leukocyte Count; D015337:Multicenter Studies as Topic; D016032:Randomized Controlled Trials as Topic; D013949:Thymus Extracts / Q000009:adverse effects / Q000627:therapeutic use*
D000276:Adjuvants, Immunologic; D013949:Thymus Extracts; C031407:thymostimulin