SAFETY AND ACTIVITY OF SAQUINAVIR IN HIV-INFECTION

被引：176

作者：

KITCHEN, VS

SKINNER, C

ARIYOSHI, K

LANE, EA

DUNCAN, IB

BURCKHARDT, J

BURGER, HU

BRAGMAN, K

PINCHING, AJ

WEBER, JN

机构：

[1] ST BARTHOLOMEWS HOSP,SCH MED,DEPT IMMUNOL,LONDON,ENGLAND

[2] ROCHE PROD LTD,WELWYN GARDEN CIT,HERTS,ENGLAND

[3] ROCHE PROD LTD,BASEL,SWITZERLAND

[4] ROCHE PROD LTD,STRASBOURG,FRANCE

来源：

LANCET | 1995年 / 345卷 / 8955期

基金：

英国医学研究理事会;

关键词：

D O I：

10.1016/S0140-6736(95)90699-1

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

We evaluated saquinavir, an orally active, selective inhibitor of HIV proteinase, in a randomised, double-blind, dose-ranging study in 49 zidovudine-naive HIV-positive patients with few or no symptoms and CD4 cell counts of 500 or less. The study was designed to assess the antiviral activity and tolerability of saquinavir. Patients were randomised to receive 25, 75, 200, or 600 mg of saquinavir three times daily for 16 weeks. No serious adverse events ocurred. CD4 cell counts showed a trend indicative of a dose response in favour of the 600 mg dosage, the maximum increase being seen around week 4. In none of the 8 patients with positive plasma viraemia at baseline did cultures become negative after treatment; peripheral blood mononuclear cell cell and plasma-viral load by culture and DNA and RNA PCR all showed a trend towards reduction at higher doses of saquinovir. Saquinavir was well tolerated in this group of previously untreated patients with few or no symptoms; this study shows that an HIV-proteinase inhibitor is active in HIV-infected patients.

引用

页码：952 / 955

页数：4

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