COMBINATION TRIAL OF DLV, ZDV AND 3TC AS INITIAL OR FOLLOWUP THERAPY (PART II)

DLV、ZDV 和 3TC 作为初始或后续治疗的联合试验（第二部分）

• 批准号: 6121105
• 负责人: PHILIP C JOHNSON
• 金额: $ 1.51万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6121105
• 关键词: AIDS therapy; HIV infections; antiAIDS agent; clinical research; combination chemotherapy; delavirdine; genotype; human immunodeficiency virus; human subject; human therapy evaluation; lamivudine; leukocyte count; phenotype; reverse transcriptase inhibitors; zidovudine

The aim of this double blind, randomized trial is to evaluate the safety and tolerance of double and triple combination therapies with and without delavirdine, a non-nucleoside reverse transcriptase inhibitor. These combinations will include DLV, zidovudine (ZDV), and lamivudine (3TC). Patients from Part I comparing ZDV with and without DLV plus new study HIV+ patients with CD4 counts of 200-500/mm3 and with 0-6 months total ZDV experience will be studied. Phenotypic and genotypic changes that emerge will also be evaluated. Interim analysis of this study showed the triple combination therapy to be better than either of the other two arms. The study was closed by the DSMB early in 1998.

本双盲、随机试验的目的是评估双药和三联疗法联合或不联合地拉韦啶（一种非核苷类逆转录酶抑制剂）的安全性和耐受性。 这些组合将包括DLV、齐多夫定（ZDV）和拉米夫定（3 TC）。将研究第I部分中比较ZDV联合和不联合DLV的患者，以及CD 4计数为200-500/mm 3且总ZDV经验为0-6个月的新研究HIV+患者。 还将评价出现的表型和基因型变化。本研究的中期分析显示三联疗法优于其他两组。 DSMB于1998年初关闭了该研究。