DMP266 020:COMBINATION OF DMP266 & INDINAVIR VS INDINAVIR IN HIV+ PAT
DMP266 020:COMBINATION OF DMP266 & INDINAVIR VS INDINAVIR IN HIV+ PAT
批准号:
6265799
负责人:
DAVID M MUSCHATT
金额:
$1.12万
依托单位国家:
美国
项目类别:
财政年份:
1999
资助国家:
美国
项目状态:
已结题
起止时间:
1999-07-19 至 1999-11-30
中文摘要
这是一项为期24周的双盲、安慰剂对照、随机多中心研究,旨在确定DMP 266和茚地那韦联合治疗hiv感染患者核苷类似物(NRTI)的有效性和耐受性。该研究的目的是评估DMP 266联合茚地那韦与茚地那韦单独治疗在同时接受nrti的hiv感染患者中抑制病毒载量的有效性。评价dmp266联合茚地那韦治疗合并NRTIs的hiv感染患者的耐受性,相对于单独使用茚地那韦。总共有300名患者将被纳入研究。研究时间约为10个月。在24周结束时,随机分配到两个治疗组的患者将选择继续使用开放标签DMP 266加Indinavir。
英文摘要
This is a 24 week, double-blind, placebo-controlled, randomized multicenter study to determine the effectiveness and tolerability of the combination of DMP 266 and Indinavir versus Indinavir in HIV-infected patient nucleoside analogue (NRTI) therapy. The objectives of the study is to evaluate the effectiveness of DMP 266 in combination with Indinavir relative to treatment with Indinavir alone on viral load suppression in HIV-infected patients concomitantly receiving NRTIs. To evaluate the tolerability of DMP 266 in combination with Indinavir relative to treatment with Indinavir alone in HIV-infected patients concomitantly receiving NRTIs. A total number of 300 patients will be enrolled. The study duration will be approximately 10 months. At the end of the 24-week period, patients randomized to both treatment groups will be given the option to continue on open-label DMP 266 plus Indinavir.
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海外基金