COMPARISON OF ANTIRETROVIRAL ACTIVITY OF 3 COMBINATION REGIMENS IN HIV+ PATIENTS

3 种联合治疗方案对 HIV 患者的抗逆转录病毒活性比较

• 批准号: 6309263
• 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: 1999
• 资助国家: 美国
• 起止时间: 1999-12-01 至 2001-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6309263
• 关键词: AIDS therapy; HIV infections; antiAIDS agent; clinical research; combination chemotherapy; drug screening /evaluation; helper T lymphocyte; human subject; human therapy evaluation; indinavir; lamivudine; reverse transcriptase inhibitors; virus RNA; zidovudine

The objective of the protocol is to compare the antiretroviral activity, both in magnitude and duration, as measured by HIN-RNA and CD4 counts as well as the safety profile of several therapies in HIV+ patients. This originally 24-week study had been extended to Week 144 with Amendment 6 and now has been extended to February 28, 2001. The purpose of the amendment was to extend the study until all patients have completed 120 weeks, to change the visit frequency to quarterly, to decrease study evaluations for each patient, and to add abdominal CT scanning of patients, allowing fat distribution to be monitored. This open-label trial involving double and triple therapy with the drugs Indinavir, ZDV, 3TC, and DMP266. DMP266 is a potent non-nucleoside reverse transcriptase inhibitor which, in vitro, inhibits HIV production from infected cells. Because of this study and others, the FDA approved DMP266 and the drug is now available as Sustiva.

该方案的目的是比较抗逆转录病毒活性（通过HIN-RNA和CD 4计数测量）的幅度和持续时间，以及几种疗法在HIV+患者中的安全性特征。这项最初的24周研究已根据修订案6延长至第144周，现在已延长至2001年2月28日。 修订的目的是延长研究直至所有患者完成120周，将访视频率改为每季度一次，减少对每例患者的研究评价，并增加患者的腹部CT扫描，以监测脂肪分布。 这项开放标签试验涉及药物Indinavir，ZDV，3 TC和DMP 266的双重和三重治疗。 DMP 266是一种有效的非核苷类逆转录酶抑制剂，在体外可抑制感染细胞产生HIV。 由于这项研究和其他研究，FDA批准了DMP 266，该药物现在可以作为Sustiva使用。