ACTG 345 PHASE I/II STUDY OF RITONAVIR IN HIV INFECTED INFANTS AND CHILDREN

ACTG 345 利托那韦治疗 HIV 感染婴儿和儿童的 I/II 期研究

• 批准号: 6114998
• 负责人: ELIZABETH G MCFARLAND
• 金额: $ 1.99万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6114998
• 关键词: HIV infections; Retroviridae; antiAIDS agent; blood chemistry; child (0-11); clinical research; clinical trial phase I; combination chemotherapy; dosage; drug screening /evaluation; human therapy evaluation; immunology; infant human (0-1 year); lamivudine; lymphocyte; pediatric AIDS; pediatric pharmacology; pharmacokinetics; protease inhibitor; ritonavir; zidovudine

This protocol will assess the pharmacokinetics, safety and tollerance of single and multiple oral doses or ritonavir monotherapy, and in combination with 3TC and ZDV in HIV-1 infected infants and children and to ascertain a dose or ritonavir which may be suitable for the Phase II/III evaluation of ritonavir. It will also evaluate the antiretroviral activity and the immunological effect of single and multiple doses of ritonavir adminstered alone or in combination therapy, to model plasma virus and lymphocyte kinetics within the treatment protocol, and to determine the rapidity with which virus resistant to ritonavir emerges in vivo.

本方案将评估单次和多次口服剂量或利托那韦单药治疗以及与3 TC和ZDV联合治疗HIV-1感染婴儿和儿童的药代动力学、安全性和耐受性，并确定可能适合利托那韦II/III期评价的利托那韦剂量。 还将评价利托那韦单次和多次给药或联合治疗的抗逆转录病毒活性和免疫学效应，以模拟治疗方案中的血浆病毒和淋巴细胞动力学，并确定利托那韦耐药病毒在体内出现的速度。