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A randomized trial of the activity and safety of Ro 24-7429 (Tat antagonist) versus nucleoside for human immunodeficiency virus infection. The AIDS Clinical Trials Group 213 Team.

Abstract
Ro 24-7429, a Tat antagonist, dosed at 75, 150, or 300 mg/day, was compared with nucleoside analogue (zidovudine or didanosine) for 12 weeks in 96 human immunodeficiency virus (HIV)-infected patients to assess safety and activity. The primary adverse effect of Ro 24-7429 was rash, which necessitated treatment discontinuation in 6 of 71 patients. Nucleoside analogue treatment produced an average increase in CD4 cell count of 28 cells/mm3 at week 8 versus a decrease of 27 cells/mm3 in recipients of Ro 24-7429 (P < .001). Serum HIV p24 antigen levels decreased by an average of 111 pg/mL in nucleoside recipients at week 8 compared with an increase of 41 pg/mL in recipients of Ro 24-7429 (P = .007). Nucleoside-treated patients had a mean 0.66 log10 reduction in infectious peripheral blood mononuclear cells, while Ro 24-7429 recipients had a mean 0.02 log10 reduction (P = .02). No dose-response relationships were observed in the Ro 24-7429 groups. In this study, Ro 24-7429 treatment showed no evidence of antiviral activity.
AuthorsR H Haubrich, C Flexner, M M Lederman, M Hirsch, C P Pettinelli, R Ginsberg, P Lietman, F M Hamzeh, S A Spector, D D Richman
JournalThe Journal of infectious diseases (J Infect Dis) Vol. 172 Issue 5 Pg. 1246-52 (Nov 1995) ISSN: 0022-1899 [Print] United States
PMID7594660 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, U.S. Gov't, Non-P.H.S., Research Support, U.S. Gov't, P.H.S.)
Chemical References
  • Antiviral Agents
  • Gene Products, tat
  • HIV Core Protein p24
  • Pyrroles
  • tat Gene Products, Human Immunodeficiency Virus
  • Benzodiazepines
  • Ro 24-7429
  • Zidovudine
  • Didanosine
Topics
  • Adult
  • Antiviral Agents (therapeutic use, toxicity)
  • Benzodiazepines (therapeutic use, toxicity)
  • CD4 Lymphocyte Count (drug effects)
  • Didanosine (therapeutic use)
  • Dose-Response Relationship, Drug
  • Female
  • Gene Products, tat (antagonists & inhibitors)
  • HIV Core Protein p24 (blood)
  • HIV Infections (drug therapy, immunology)
  • Humans
  • Male
  • Middle Aged
  • Pyrroles
  • Time Factors
  • Zidovudine (therapeutic use)
  • tat Gene Products, Human Immunodeficiency Virus

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