Human immunodeficiency virus type 1 quantitative cell microculture as a measure of antiviral efficacy in a multicenter clinical trial

Susan A. Fiscus, Victor De Gruttola, Phalguni Gupta, David A. Katzenstein, William A. Meyer, Marsha L. Lo Faro, Michael Katzman, Margaret V. Ragni, Patricia S. Reichelderfer, Robert W. Coombs

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41 Scopus citations

Abstract

A Quantitative cell microculture assay (QMC) was used to measure the human immunodeficiency virus type 1 (HIV-1) peripheral blood mononuclear cell (PBMC)-associated titer in 109 subjects enrolled in an open-label phase I/II study of didanosine monotherapy or combination therapy with zidovudine, The titer was inversely correlated with C04+cell count at baseline (r =.37, P =.001). After 12 weeks of therapy, subjects showed a significant decreases in virus titer and those with the highest baseline virus titers had the greatest increase in C04+cell number (r =.430, P =.002). The QMC assay was more sensitive (98%) for assessing the antiretroviral effect of therapy than was immune complex-dissociated HIV p24 antigen (32%) or plasma culture (3.4%). Estimated sample sizes for phase I/II clinical trials were derived using the within-subject QMC SO of.72 log10infectious units per 106PMBC.

Original languageEnglish (US)
Pages (from-to)305-311
Number of pages7
JournalJournal of Infectious Diseases
Volume171
Issue number2
DOIs
StatePublished - Feb 1995

All Science Journal Classification (ASJC) codes

  • Immunology and Allergy
  • Infectious Diseases

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    Fiscus, S. A., De Gruttola, V., Gupta, P., Katzenstein, D. A., Meyer, W. A., Lo Faro, M. L., Katzman, M., Ragni, M. V., Reichelderfer, P. S., & Coombs, R. W. (1995). Human immunodeficiency virus type 1 quantitative cell microculture as a measure of antiviral efficacy in a multicenter clinical trial. Journal of Infectious Diseases, 171(2), 305-311. https://doi.org/10.1093/infdis/171.2.305