Results of a double-blind placebo-controlled study of the double-stranded RNA drug polyI:polyC12U in the treatment of HIV infection

• Published in: European journal of clinical microbiology & infectious diseases Vol. 15; no. 7; pp. 580 - 587
• Main Authors: THOMPSON, K. A, STRAYER, D. R, SALVATO, P. D, THOMPSON, C. E, KLIMAS, N, MOLAVI, A, HAMILL, A. K, ZHENG, Z, VENTURA, D, CARTER, W. A
• Format: Journal Article
• Language: English
• Published: Berlin Springer 01-07-1996
• Subjects: Acquired Immunodeficiency Syndrome - etiology; Adult; Anti-HIV Agents - adverse effects; Anti-HIV Agents - therapeutic use; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antiviral agents; Antiviral Agents - adverse effects; Antiviral Agents - therapeutic use; Biological and medical sciences; Candida albicans - immunology; CD4 Lymphocyte Count; Cross-Over Studies; Disease Progression; Double-Blind Method; Drug Hypersensitivity; Drug Therapy, Combination; Female; HIV Core Protein p24 - analysis; HIV Infections - drug therapy; Humans; Hypersensitivity, Delayed; Male; Medical sciences; Middle Aged; Mumps - immunology; Pharmacology. Drug treatments; Poly I-C - adverse effects; Poly I-C - therapeutic use; Poly U - adverse effects; Poly U - therapeutic use; RNA, Double-Stranded; Skin Tests; Tetanus - immunology; Trichophyton - immunology; Zidovudine - adverse effects; Zidovudine - therapeutic use; Infection; Human; Immunopathology; Chemotherapy; Double stranded RNA; Treatment; Viral disease; Treatment efficiency; Double blind study; AIDS; Immune deficiency
• ISSN: 0934-9723; 1435-4373
• DOI: 10.1007/bf01709367

In this multicenter, randomized, double-blind study the activity of polyI:polyC12U administered with zidovudine was evaluated in the treatment of HIV infection. Thirty-six HIV-positive, pre-AIDS individuals (100-500 CD4+ cells/mm3) who had had at least six months of zidovudine therapy received polyI:polyC12U (400 or 700 mg) or placebo twice weekly with zidovudine. PolyI:polyC12U subjects with baseline CD4+ counts > or = 300/mm3 showed a trend towards reduced CD4+ loss versus placebo recipients. PolyI:polyC12U subjects were more likely to exhibit positive delayed-type hypersensitivity responses than placebo recipients. Placebo subjects crossing over to polyI:polyC12U therapy demonstrated improved CD4+ and delayed-type hypersensitivity responses. PolyI:polyC12U subjects with baseline CD4+ counts > or = 300/mm3 were less likely to develop AIDS than similar placebo subjects. PolyI:polyC12U therapy of HIV-positive subjects restored or stabilized immune function as indexed by delayed-type hypersensitivity reactivity and, in individuals with CD4+ counts > 300/mm3, abrogated CD4+ loss and reduced disease progression. PolyI:polyC12U was generally well-tolerated in this zidovudine-treated population. No subject discontinued therapy due to an adverse reaction or aberrant laboratory parameter.