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.
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Authors | R 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 |
Journal | The Journal of infectious diseases
(J Infect Dis)
Vol. 172
Issue 5
Pg. 1246-52
(Nov 1995)
ISSN: 0022-1899 [Print] United States |
PMID | 7594660
(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.)
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Chemical References |
- Antiviral Agents
- Gene Products, tat
- HIV Core Protein p24
- Pyrroles
- tat Gene Products, Human Immunodeficiency Virus
- Benzodiazepines
- Ro 24-7429
- Zidovudine
- Didanosine
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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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