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临床试验/NCT00002178
NCT00002178已完成3 期

A Phase IIIB Open-Label, Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) Treatment in Combination With Other Antiretrovirals in HIV-1 Infected Antiretroviral-Naive Patients

Hoffmann-La Roche4 个研究点 分布在 1 个国家目标入组 375 人开始时间: 2001年8月31日最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
375
试验地点
4

研究概览

简要总结

To determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of detection (< 400 copies/ml) at week 16 and 24 of study therapy. To determine the absolute change in plasma HIV-1 RNA and in absolute CD4 cell count during the 24 weeks of study treatment. To collect safety data on the treatment regimens. To determine the percentage of patients without SQV soft gel capsules resistance-associated mutations at week 24.

详细描述

Patients are randomized to receive 1 of 3 study regimens: Group A - Saquinavir (SQV) soft gel capsules (sgc) plus 2 reverse transcriptase inhibitors (RTIs), Group B - SQV sgc plus delavirdine plus RTI, and Group C - SQV sgc plus nelfinavir plus RTI (or SQV sgc plus ritonavir plus 2 RTIs).

研究设计

研究类型
Interventional
主要目的
Treatment

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究者

申办方类型
Industry

研究点 (4)

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