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1996-02-26
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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
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).