BIS-POM PMEA IN CHILDREN WITH HIV-1 INFECTION

BIS-POM PMEA 用于 HIV-1 感染儿童

• 批准号: 6114237
• 负责人: RODNEY WILLOUGHBY
• 金额: $ 2.06万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 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/6114237
• 关键词: AIDS therapy; adenine analog; antiAIDS agent; child (0-11); clinical research; clinical trial phase I; drug screening /evaluation; human immunodeficiency virus 1; human subject; human therapy evaluation; pediatric AIDS; prodrugs

This Phase I trial for safety and efficacy of a novel drug against human immunodeficiency virus (HIV) requires adequate representation across the pediatric age spectrum. Escalation in dosage requires completion of all age strata. Very few HIV-infected children have been identified under age 2 years, reflecting the success of AZT prophylaxis against maternal to infant transmission. Escalation of ACTG 310 was stymied because of lack of enrollment of younger children. An intensive effort at our insstitution resulted in enrollment of the entire national age < 2 yrs cohort, estabolishing safety and bioavailability, and promoting subsequent escalation in dosage of the trial. We anticipate providing additional representation inthis crucial age range at the higher drug dosage. Successful completion of this trial will lead to an efficacy trial of adefovir dipivoxil in children. Adefovir is the first drug against HIV targeted for early trials in children concurrent with trials in adults. Early trials in children are necessary to address the severe shortage of anti-HIV drugs in children relative to adults ( 3 vs 10 drugs available in 1996). Adefovir is currently in early trials in adults as part of new generation "cocktails" in combination with protease inhibitors. Pediatric trials should follow shortly. Adefovir is likely to improve pediatric HIV care, providing more options for "pediatric cocktails" against HIV. The drug has promising activity against cytomegalovirus, an HIV co-pathogen in children, making it doubly attractive.

一种新型抗人类药物的安全性和有效性的I期试验 免疫缺陷病毒(HIV)需要有足够的代表性 儿科年龄谱。剂量的递增需要完成所有 年龄层。很少有感染艾滋病毒的儿童被确认为 2岁，反映AZT预防孕产妇死亡的成功 到婴儿传播。ACTG 310的升级受到阻碍，原因是 年龄较小的儿童入学人数不足。我们的一项密集的努力 这一制度导致了整个国家年龄和2岁的入学 队列，废除安全性和生物利用度，并促进 随后试验的剂量逐步增加。我们预计会提供 在这一关键年龄范围内的额外代表在更高的药物 剂量。 成功完成这项试验将导致一项疗效试验 阿德福韦酯用于儿童。阿德福韦是第一种治疗艾滋病毒的药物 目标是在成人试验的同时，对儿童进行早期试验。 有必要对儿童进行早期试验，以解决严重的短缺问题。 儿童抗艾滋病毒药物相对于成人(3种药物对10种药物 1996年推出)。阿德福韦目前正处于成人早期试验阶段 作为新一代鸡尾酒的一部分，与蛋白酶相结合 抑制剂。儿科试验应该很快就会接踵而至。阿德福韦是 可能改善儿科艾滋病毒护理，为 对抗艾滋病毒的“儿科鸡尾酒”。这种药物有很好的活性。 抗巨细胞病毒，一种儿童艾滋病毒的共同病原体，使其 魅力倍增。