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

包含蛋白酶抑制剂与保留蛋白酶抑制剂的随机试验

• 批准号: 7603911
• 负责人: ALICE STEK
• 金额: $ 1.38万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603911
• 关键词: AIDS clinical trial group; Acquired Immunodeficiency Syndrome; Area; Combination Chemotherapy; Combination Drug Therapy; Computer Retrieval of Information on Scientific Projects Database; Drug Kinetics; Enrollment; Evaluation; Funding; Gestational Diabetes; Grant; Infant; Institution; Nelfinavir; Nevirapine; Personal Satisfaction; Postpartum Period; Pregnancy; Protease Inhibitor; Protocols documentation; Randomized Clinical Trials; Randomized Controlled Clinical Trials; Research; Research Design; Research Personnel; Resources; Source; Standards of Weights and Measures; Testing; United States National Institutes of Health; Week; Woman; Writing; design; experience; follow-up

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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 该研究是一项多中心、ACTG随机临床试验，涉及400名女性及其妊娠，其中6名将在LAC+USC进行。 该研究设计非常出色，为两个研究组提供了3种药物联合治疗，仅改变奈韦拉平和奈非那韦组分。 产后34周和8周还将进行药代动力学评估。 GCRC将用于这些评价。 妊娠期糖尿病的检测也将按照标准方案进行。 还计划对婴儿进行适当随访，以便有机会长期入组PACTG 291 G试验。 （艾滋病） 该研究报告是由一个在这方面具有丰富专业知识的经验丰富的研究小组编写和设计的。