Comparative studies of two-times-daily versus three-times-daily indinavir in combination with zidovudine and lamivudine.
AIDS
; 14(13): 1973-8, 2000 Sep 08.
Article
em En
| MEDLINE
| ID: mdl-10997402
ABSTRACT
OBJECTIVES:
To compare the efficacy and safety of two-times-daily versus three-times-daily indinavir in combination with zidovudine and lamivudine.DESIGN:
Two multicenter, open-label, randomized 24-week studies.METHODS:
Adults HIV-1 infection, HIV-1 RNA greater than 10000 copies/ml, and no prior lamivudine or protease inhibitor therapy were eligible. In a pilot study (Study A), patients received indinavir at 800 mg every 8 h, 1000 mg every 12 h, or 1200 mg every 12 h. In a subsequent study (Study B), patients received indinavir at 800 mg every 8 h or 1200 mg every 12 h. All subjects received zidovudine (300 mg) and lamivudine (150 mg) every 12 h. An intent-to-treat analysis was used.RESULTS:
In Study A, which enrolled 88 patients, neither HIV-1 RNA nor CD4 cell responses differed significantly between treatment groups at 24 weeks when corrected for multiple comparisons. Study B enrolled 433 patients, but was prematurely discontinued when interim analysis suggested greater efficacy of three-times-daily indinavir. Of the first 87 patients reaching week 24, HIV-1 RNA was less than 400 copies/ml in 91% receiving three-times-daily versus 64% receiving two-times-daily indinavir (P < 0.01).CONCLUSION:
Three-times-daily indinavir appears more efficacious than two-times-daily dosing when administered with zidovudine and lamivudine. Two-times-daily indinavir dosing should only be considered in situations characterized by favorable pharmacokinetic drug-drug interactions.
Buscar no Google
Base de dados:
MEDLINE
Assunto principal:
Zidovudina
/
Infecções por HIV
/
Inibidores da Transcriptase Reversa
/
Indinavir
/
Lamivudina
/
Fármacos Anti-HIV
Idioma:
En
Ano de publicação:
2000
Tipo de documento:
Article