Didanosine compared with continuation of zidovudine in HIV-infected patients with signs of clinical deterioration while receiving zidovudine. A randomized, double-blind clinical trial. The Bristol-Myers Squibb AI454-010 Study Group.
Ann Intern Med
; 120(5): 360-8, 1994 Mar 01.
Article
em En
| MEDLINE
| ID: mdl-7905722
ABSTRACT
OBJECTIVE:
To determine the benefits of switching to didanosine compared with continuing zidovudine among patients infected with human immunodeficiency virus (HIV) who have previously used zidovudine and have signs of clinical deterioration.DESIGN:
Randomized, double-blind, two-armed, parallel, comparative clinical trial with a blinded, compassionate crossover provision at 12 weeks.SETTING:
Outpatient clinics at 19 tertiary care medical centers. PATIENTS 312 patients infected with HIV who had received zidovudine for 6 months or more, had CD4 cell counts of 300/mm3 or less, and had signs of clinical deterioration within 12 weeks before study entry. INTERVENTION Peroral didanosine tablets (600 mg/d adjusted for weight, "high dose") or zidovudine capsules (600 mg/d). MEASUREMENTS Primary study end points were death, a new acquired immunodeficiency syndrome (AIDS)--defining event, or the combination of two new or recurrent HIV-related diagnoses with a 50% decrease in CD4 cells.RESULTS:
Switching to didanosine was associated with fewer end points than continuing zidovudine (relative risk [RR] for zidovudinedidanosine = 1.5; 95% Cl, 1.1 to 2.0). This benefit was consistent across subgroups of patients with either AIDS-related complex or AIDS and was most apparent among those with a CD4 count at entry of 100/mm3 or more (RR = 2.2; Cl, 1.1 to 4.4).CONCLUSIONS:
This study shows a positive treatment effect for switching from zidovudine to didanosine among patients with either AIDS-related complex or AIDS and validates the common practice of using clinical signs or a decrease in the CD4 count as an indication for changing therapy.
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Base de dados:
MEDLINE
Assunto principal:
Zidovudina
/
Complexo Relacionado com a AIDS
/
Síndrome da Imunodeficiência Adquirida
/
Didanosina
Idioma:
En
Ano de publicação:
1994
Tipo de documento:
Article