Results of a double-blind placebo-controlled study of the double-stranded RNA drug polyI:PolyC12U in the treatment of HIV infection
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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.
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- Results of a double-blind placebo-controlled study of the double-stranded RNA drug polyI:PolyC12U in the treatment of HIV infection
European Journal of Clinical Microbiology and Infectious Diseases
Volume 15, Issue 7 , pp 580-587
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- 1. Hemispherx Biopharma Incorporated, 1617 JFK Boulevard, Suite 660, 19103, Philadelphia, Pennsylvania, USA
- 2. Department of Medicine, Medical College of Pennsylvania and Hahnemann University, MS 412 Broad and Vine Streets, 19102, Philadelphia, Pennsylvania, USA
- 3. Houston Immunological Institute, Houston, Texas, USA
- 4. Immunology Clinic No. 4, Veterans Administration Medical Center, Miami, Florida, USA
- 5. Nelson-Tebedo Community Clinic, Dallas, Texas, USA