RANDOMIZED TRIAL OF PROTEASE INHIBITOR-INCLUDING VS PROTEASE INHIBITOR-SPARING

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这项研究是一项多中心的ACTG随机临床试验，涉及400名妇女及其怀孕，其中6名将在拉丁美洲和加勒比南加州大学进行。这项研究设计出色，为两个研究组都提供了3种药物的联合治疗，只改变了奈韦拉平和奈非那韦的成分。还将在产后34周和8周进行药代动力学评估。GCRC将用于这些评估。妊娠期糖尿病检测也将按照标准方案进行。还计划对婴儿进行适当的后续治疗，并有机会长期参加PACTG 291G试验。(艾滋病) 这项研究由一个在这一领域拥有丰富专业知识的经验丰富的研究小组撰写和设计得很好。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The study is a multi-center, ACTG randomized clinical trial involving 400 women and their pregnancies, of which 6 will be done at LAC+USC. The study design is excellent offering 3-drug combination therapy to both study groups, varying only the nevirapine and nelfinavir components. There also will be pharmacokinetic evaluations at 34 weeks and 8 weeks postpartum. The GCRC will be used to for these evaluations. Testing for gestational diabetes will also be done following standard protocol. Appropriate follow-up of the infant is also planned with opportunity for long-term enrollment into the PACTG 291G trial. (AIDS) The study is well written and well designed, by an experienced study group with great expertise in this area.