Document 0507
 DOCN  M9620507
 TI    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.
 DT    9602
 AU    Haubrich RH; Flexner C; Lederman MM; Hirsch M; Pettinelli CP; Ginsberg
       R; Lietman P; Hamzeh FM; Spector SA; Richman DD; Department of Medicine,
       University of California, San Diego.
 SO    J Infect Dis. 1995 Nov;172(5):1246-52. Unique Identifier : AIDSLINE
       MED/96036380
 AB    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.
 DE    Adult  Antiviral Agents/*TOXICITY/*THERAPEUTIC USE
       Benzodiazepines/*TOXICITY/*THERAPEUTIC USE  Comparative Study  CD4
       Lymphocyte Count/*DRUG EFFECTS  Didanosine/THERAPEUTIC USE
       Dose-Response Relationship, Drug  Female  Gene Products, tat/ANTAGONISTS
       & INHIB  Human  HIV Core Protein p24/BLOOD  HIV Infections/*DRUG
       THERAPY/IMMUNOLOGY  Male  Middle Age  Support, U.S. Gov't, Non-P.H.S.
       Support, U.S. Gov't, P.H.S.  Time Factors  Zidovudine/THERAPEUTIC USE
       CLINICAL TRIAL  JOURNAL ARTICLE  RANDOMIZED CONTROLLED TRIAL

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