INTENSIVE PHARMACOKINETIC STUDIES OF ANTIRETROVIRAL DRUG COMBINATIONS HIV

抗逆转录病毒药物组合 HIV 的深入药代动力学研究

• 批准号: 8174501
• 负责人: MARGARET A KELLER
• 金额: $ 0.86万
• 依托单位: LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-12-01 至 2010-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8174501
• 关键词: 18 year old; Adolescent; Anti-Retroviral Agents; Body Surface Area; Child; Computer Retrieval of Information on Scientific Projects Database; Drug Combinations; Drug Kinetics; Funding; Grant; Hour; Institution; Nucleosides; Pharmaceutical Preparations; Protease Inhibitor; Regimen; Research; Research Personnel; Resources; Reverse Transcriptase Inhibitors; Ritonavir; Sampling; Source; Tenofovir; United States National Institutes of Health; dosage; interest; non-nucleoside reverse transcriptase inhibitors

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. P1058 Version 2.0 is an intensive 24-hour pK study of the pharmacokinetics of selected antiretroviral drugs in HIV-infected children > or <18 years of age who are receiving or about to initiate a regimen of antiretrovirals that includes one of the drugs or drug combinations of interest. The objectives are divided into three groups. 1) Assess the steady state by pK sampling of orally administered tenofovir given in combination with nucleoside reverse transcriptase inhibitors (NRTI) and non-nucleoside reverse transcriptase inhibitors (NNRTI) to older children and adolescents. 2) Assess the steady state by pK sampling of orally administered concomitant therapies such as boosted protease inhibitors (PI) such as darunavir/ritonavir used with tenofovir in older children and adolescents. 3) Describe the relationship between a subject?s body surface area (BSA) and tenofovir exposure during treatment with a fixed dosage at steady state with or without concomitant PI treatment.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 P1058版本2.0是一项针对HIV感染儿童选定抗逆转录病毒药物的药代动力学的24小时PK研究，他们正在接受或即将接受或即将启动包括一种包括感兴趣的药物或药物组合的抗逆转录病毒治疗方案。 目标分为三组。 1）通过对核苷逆转录酶抑制剂（NRTI）和非核苷逆转录酶抑制剂（NNRTI）组合对口服给药的替诺福利的PK采样来评估稳态。 2）通过PK对口服施用的伴随疗法进行PK采样，例如增强的蛋白酶抑制剂（PI），例如与Tenofovir一起在大儿童和青少年中与Tenofovir一起使用的Darunavir/Ritonavir。 3）描述受试者的身体表面积（BSA）和替诺福韦在稳态下进行固定剂量治疗期间的关系，无论有或不带有PI治疗。