Results of a double-blind placebo-controlled study of the double-stranded RNA drug polyI:PolyC12U in the treatment of HIV infection

  • K. A. Thompson
  • D. R. Strayer
  • P. D. Salvato
  • C. E. Thompson
  • N. Klimas
  • A. Molavi
  • A. K. Hamill
  • Z. Zheng
  • D. Ventura
  • W. A. Carter
Article

DOI: 10.1007/BF01709367

Cite this article as:
Thompson, K.A., Strayer, D.R., Salvato, P.D. et al. Eur. J. Clin. Microbiol. Infect. Dis. (1996) 15: 580. 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≥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≥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.

Copyright information

© MMV Medizin Verlag GmbH 1996

Authors and Affiliations

  • K. A. Thompson
    • 1
  • D. R. Strayer
    • 2
  • P. D. Salvato
    • 3
  • C. E. Thompson
    • 3
  • N. Klimas
    • 4
  • A. Molavi
  • A. K. Hamill
    • 5
  • Z. Zheng
    • 1
  • D. Ventura
    • 1
  • W. A. Carter
    • 1
  1. 1.Hemispherx Biopharma IncorporatedPhiladelphiaUSA
  2. 2.Department of MedicineMedical College of Pennsylvania and Hahnemann UniversityPhiladelphiaUSA
  3. 3.Houston Immunological InstituteHoustonUSA
  4. 4.Immunology Clinic No. 4Veterans Administration Medical CenterMiamiUSA
  5. 5.Nelson-Tebedo Community ClinicDallasUSA

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