NCT00242840已完成3 期
A 24 Week Phase IIIb/IV Single Arm Open Label Observational Study to Explore the Efficacy of Protease Inhibitors Given in Combination With Reverse Transcriptase Inhibitors to HIV-1 Infected Subjects With Protease Mutations Selected During Therapy With GW433908 Containing Antiretroviral Therapy
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 7
研究概览
简要总结
This study will assess the efficacy of subsequent protease inhibitor (PI)-containing therapy in subjects who have acquired HIV-1 protease mutations whilst receiving a GW433908 (fosamprenavir)-containing regimen.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior participation in study APV30005 AND one of the following studies: APV30001, APV30002, AZL30006, APV
- •Must be failing virologically (>1000 copies at two consecutive time-points) and have a screening genotype with evidence of at least one new APV-associated protease mutation: V32I (+/- I47V), I50V, I54L/M, I84V acquired since commencing treatment with GW433908.
排除标准
- •Have 2 or more of the primary resistance mutations D30N, G48V, V82A/F/T/S and L90M.
- •Have a medical need for use of an non-nucleoside reductase transferase inhibitor (NNRTI).
- •Have an acute CDC Class C event requiring therapeutic intervention.
- •Are pregnant or lactating.
- •Have any other condition which in the opinion of the investigator would preclude their participation.
研究者
研究点 (7)
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