RITONAVIR (ABT 538) + LAMIVUDINE AND ZIDOVUDINE IN PATIENTS NEWELY INFECTED WITH

利托那韦 (ABT 538) 拉米夫定和齐多夫定用于新感染的患者

• 批准号: 6246947
• 负责人: Martin H Markowitz
• 金额: $ 5.86万
• 依托单位: ROCKEFELLER UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-01-27 至 1997-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6246947
• 关键词: AIDS therapy; HIV infections; antiAIDS agent; antiviral agents; clinical research; clinical trials; combination chemotherapy; drug screening /evaluation; human subject; human therapy evaluation; zidovudine

This is a multiple-dose, single-center, triple-drug combination clinical trial in patients newly infected with HIV-1. The objectives of the study are to evaluate the safety and antiviral activity of combination therapy with Zidovudine, Lamivudine and Ritonavir and to assess the acute effect of the triple-drug combination on viral kinetics in the circulating cellular and plasma compartments. The study involved the recruitment of 12 patients who were within 90 days of infection, as determined by positive plasma HIV RNA and either negative or evolving antibody response. Eight of the nine remaining on study have shown a marked reducation in viral load, and all patients have shown a notable rise in absolute CD4 count and CD4/CD8 ratio. Future studies will involve analysis of lymphoid tissue for presense of virus; immunologic responses to therapy, both humoral and cellular; and VB repertoire and naive/memory subsets will be determined to assess the recovery capacity of the immune system post therapy in both acute and chronic infection. The testing of eradication remains a goal.

这是一个多剂量、单中心、三联用药的临床试验。 在新感染HIV-1的患者中进行试验。研究的目标 评估联合治疗的安全性和抗病毒活性 分别用齐多夫定、拉米夫定和利托那韦治疗，并评价其急性疗效 三联用药对循环中病毒动力学的影响 细胞室和质室。这项研究涉及招聘 12名感染后90天内的患者，由 血浆HIVRNA阳性，抗体反应阴性或进化。 在剩下的9名研究人员中，有8人的人数在 病毒载量，所有患者的绝对CD_4均显著升高 CD_4/CD_8比值。未来的研究将涉及淋巴组织的分析。 病毒存在的组织.对治疗的免疫学反应 体液和细胞；VB曲目和幼稚/记忆子集将是 决心评估免疫系统的恢复能力后 治疗急性和慢性感染。根除试验 仍然是一个目标。