ACTG 333--HARD CAPSULE AND SOFT CAPSULE SAQUINAVIR VS INDINAVIR

ACTG 333--硬胶囊和软胶囊沙奎那韦与印地那韦

• 批准号: 6275389
• 负责人: Robert Turner Schooley
• 金额: $ 3.14万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-12-01 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6275389
• 关键词: AIDS therapy; HIV infections; antiAIDS agent; antiviral agents; clinical research; clinical trials; drug administration rate /duration; drug screening /evaluation; human immunodeficiency virus; human subject; human therapy evaluation; microcapsule; microorganism disease chemotherapy; protease inhibitor; pyridine; quinoline

This study randomized 3 arm multicenter open label trial in sqvhc experienced subjects. Subjects were randomized to receive either (arm 1) a continuation of the hard capsule saquinavir (sqvhc) or (arm 2) the new soft gelatin capsule of saquinavir (sqvsgc) which replaced the sqvhc in their drug regimen or (arm 3) indinavir (idv) which replaced the sqvhc in their drug regimen. Subjects continued on their same non-protease anti- HIV drugs, if on any therapy, for at least the first 8 weeks. An interim analysis was performed after 72 subjects had completed 8 weeks of the trial. This interim analysis was not in the original protocol design but was incorporated into version 2.0 Of the protocol because accrual was slower than anticipated. The primary objective of the interim analysis was to examine the 8 week changes in HIV-RNA in the IDV and sqvsgc arms and ensure that they were large enough for the study to continue. The guidelines developed by the study team suggested that if either arm did not show acute HIV-RNA reduction of at least 0.7 Log 10 compared to sqvhc, the arm was to be considered for termination.

本研究在sqvhc中进行了随机化3组多中心开放标签试验 经验丰富的科目。 受试者被随机分配接受（第1组） 继续使用硬胶囊沙奎那韦（sqvhc）或（arm 2）新的 沙奎那韦软胶囊（SQVSGC）， 他们的药物方案或（组3）茚地那韦（idv）， 他们的药物疗法 受试者继续接受相同的非蛋白酶抗- HIV药物，如果在任何治疗中，至少前8周。 临时 在72名受试者完成8周的治疗后进行分析。 审判该中期分析不在原始方案设计中，但 纳入方案2.0版，因为 比预期的要慢。 中期分析的主要目的 是检查IDV和sqvsgc组8周内HIV-RNA的变化 并确保它们足够大以供研究继续进行。的 研究小组制定的指导方针建议， 与sqvhc相比，未显示急性HIV-RNA降低至少0.7 Log 10， 将考虑终止该手臂。