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

该方案的目的是比较通过HIN-RNA和CD4计数测量的抗逆转录病毒活性的大小和持续时间，以及几种治疗方法在HIV+患者中的安全性。最初为期24周的研究已根据第六修正案延长至第144周，现在已延长至2001年2月28日。修订的目的是将研究延长至所有患者完成120周，将访问频率改为每季度一次，减少对每位患者的研究评估，并增加患者的腹部CT扫描，以便监测脂肪分布。这项开放标签试验包括使用药物Indinavir、ZDV、3TC和DMP266进行双联和三联治疗。DMP266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DMP266，该药物现在以Sustiva的名称上市。

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.