CLINICAL TRIALS IN HIV INFECTED CHILDREN

HIV 感染儿童的临床试验

• 批准号: 3727100
• 负责人: CATHERINE M WILFERT
• 金额: --
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/3727100
• 关键词: 2'3' dideoxycytidine; 2'3' dideoxyinosine; AIDS dementia complex; AIDS therapy; AIDS vaccines; African American; CD4 molecule; HIV infections; Mycobacterium; Pneumocystis pneumonia; acyclovir; adolescence (12-20); antiAIDS agent; child (0-11); clinical trials; combination chemotherapy; exotoxins; human herpesvirus 6; human subject; human therapy evaluation; measles; methylprednisolone; opportunistic infections; pediatric AIDS; perinatal; placebos; zidovudine

The Duke Pediatric Aids Treatment Team has been engaged in clinical treatment trials for children with HIV infection since he all of 1986. Duke participated in the pediatric Phase I studies on zidovudine (ZDV), and has continued to treat the patients originally on that protocol. Patients (as many as five) have recently begun enrolling in the collaborative Phase II, open label (uncontrolled) study of zidovudine efficacy in children with AIDS (other than LIP alone) or severe ARC (<500 CD4+ cells). After enrollment in this study is full, an "extension" will initiated, wherein additional qualifying patients can be enrolled in an identical protocol with separate analysis. Some patients in the extension will be randomized as to whether they will also receive intravenous immunoglobulin. Beginning in the near future, a collaborative Phase II, double-blind, placebo-controlled study of oral ZDV in children with LIP or ARC will open for enrollment. It is anticipated the Duke will be able to enroll 20-30 patients in this 2 year study. The final category of study in this proposal serves as the underpinning for three of the research projects (Projects 3, 4, and 5) in this application. Duke pediatrics will be participating in a Phase I study of I.V. and P.O. ZDV in newborn infants. After the conclusion of this study, which requires substantial amounts of blood for pharmaco kinetics, it is proposed to initiate a Phase II, double-blind, placebo-controlled study of neonatal prophylaxis using ZDV. If viral acquisition is a late gestational or perinatal event, the rapid use of ZDV may prevent virus acquisition. A short course of ZDV or placebo would be administered orally from immediately after birth, and the children followed intensively for one year. The intensive follow-up would be used to provide natural history information, as well as family/social intervention and evaluation. Because HIV transmission is only around 35-50% from infected mothers to infants, the double blind trial would have four populations: treated-infected, untreated-infected, treated-uninfected, and untreated-uninfected. Because of this design, accurate information separating disease from drug effects will be obtained. Special attention will be directed at areas of concern which have already been uncovered in studies to date: intellectual, social, and motor development; neurological sequelae of infection; cardiac disease (Project 2); renal disease; and dental development.

杜克大学儿科艾滋病治疗团队一直从事临床 自 1986 年以来，杜克大学一直在对感染艾滋病毒的儿童进行治疗试验 参与了齐多夫定（ZDV）的儿科 I 期研究，并已 继续治疗最初按照该方案的患者。患者（如 多达五个）最近开始参加合作第二阶段， 齐多夫定对儿童的疗效的开放标签（非对照）研究 AIDS（单独的 LIP 除外）或严重 ARC（<500 个 CD4+ 细胞）。后 本研究的入组人数已满，将启动“延期”，其中 其他符合条件的患者可以参加相同的方案 并单独分析。延期中的一些患者将被随机分组 他们是否也会接受静脉注射免疫球蛋白。开始 在不久的将来，合作的第二阶段，双盲， LIP 或 ARC 儿童口服 ZDV 的安慰剂对照研究即将开展 以便报名。预计杜克大学将能够招收 20-30 名学生 参与这项为期 2 年研究的患者。 本提案中的最后一个研究类别是以下研究的基础 本申请中的三个研究项目（项目 3、4 和 5）。 杜克儿科将参与 I.V. 的 I 期研究。和邮政信箱 新生儿 ZDV。本研究结束后，需要 大量血液用于药代动力学研究，建议 启动一项针对新生儿的 II 期、双盲、安慰剂对照研究 使用 ZDV 进行预防。如果病毒感染发生在妊娠晚期或 围产期事件中，快速使用 ZDV 可能会阻止病毒感染。一个 短期 ZDV 或安慰剂口服给药 出生后立即，孩子们紧随其后 年。密集的后续行动将用于提供自然历史 信息以及家庭/社会干预和评估。因为 受感染母亲向婴儿传播艾滋病毒的比例仅为约 35-50%， 双盲试验将有四个人群：接受治疗的感染者、 未治疗-感染、治疗-未感染和未治疗-未感染。因为 通过这种设计，可以将疾病与药物作用区分开来的准确信息 将获得。将特别关注关注领域 迄今为止的研究已经揭示了这些：智力、社会、 和运动发展；感染的神经后遗症；心脏病 （项目2）；肾脏疾病；和牙齿发育。