title: Results of a double-blind placebo-controlled study of the double-stranded RNA drug polyI:polyC12U in the treatment of HIV infection.
abstract: 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.
authors.affiliation: Hemispherx Biopharma Incorporated, Philadelphia, Pennsylvania 19103, USA.
authors.forename: K A
authors.initials: KA
authors.lastname: Thompson
authors.forename: D R
authors.initials: DR
authors.lastname: Strayer
authors.forename: P D
authors.initials: PD
authors.lastname: Salvato
authors.forename: C E
authors.initials: CE
authors.lastname: Thompson
authors.forename: N
authors.initials: N
authors.lastname: Klimas
authors.forename: A
authors.initials: A
authors.lastname: Molavi
authors.forename: A K
authors.initials: AK
authors.lastname: Hamill
authors.forename: Z
authors.initials: Z
authors.lastname: Zheng
authors.forename: D
authors.initials: D
authors.lastname: Ventura
authors.forename: W A
authors.initials: WA
authors.lastname: Carter
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000209:etiology; D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D002176:Candida albicans / Q000276:immunology; D018592:Cross-Over Studies; D018450:Disease Progression; D004311:Double-Blind Method; D004342:Drug Hypersensitivity; D004359:Drug Therapy, Combination; D005260:Female; D016655:HIV Core Protein p24 / Q000032:analysis; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D006968:Hypersensitivity, Delayed; D008297:Male; D008875:Middle Aged; D009107:Mumps / Q000276:immunology; D011070:Poly I-C / Q000009:adverse effects / Q000627:therapeutic use*; D011072:Poly U / Q000009:adverse effects / Q000627:therapeutic use*; D012330:RNA, Double-Stranded; D012882:Skin Tests; D013742:Tetanus / Q000276:immunology; D014249:Trichophyton / Q000276:immunology; D015215:Zidovudine / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D019380:Anti-HIV Agents; D000998:Antiviral Agents; D016655:HIV Core Protein p24; D012330:RNA, Double-Stranded; D011072:Poly U; D015215:Zidovudine; C047490:poly(I).poly(c12,U); D011070:Poly I-C