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

Eur J Clin Microbiol Infect Dis. 1996 Jul;15(7):580-7. doi: 10.1007/BF01709367.

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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Acquired Immunodeficiency Syndrome / etiology
  • Adult
  • Anti-HIV Agents / adverse effects
  • Anti-HIV Agents / therapeutic use
  • Antiviral Agents / adverse effects
  • Antiviral Agents / therapeutic use*
  • CD4 Lymphocyte Count
  • Candida albicans / immunology
  • 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
  • Middle Aged
  • Mumps / immunology
  • 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

Substances

  • Anti-HIV Agents
  • Antiviral Agents
  • HIV Core Protein p24
  • RNA, Double-Stranded
  • Poly U
  • Zidovudine
  • poly(I).poly(c12,U)
  • Poly I-C