BIS-POM PMEA IN CHILDREN WITH HIV-1 INFECTION

这是一项关于一种新药对人类的安全性和有效性的I期试验， 免疫缺陷病毒（艾滋病毒）需要在整个联合国系统有足够的代表性。 儿科年龄谱。 剂量递增需要完成所有 年龄层 很少有感染艾滋病毒的儿童被确定为未成年人 2年，反映了艾滋病预防对孕产妇死亡的成功， 婴儿传染 ACTG 310的升级由于缺乏 年龄较小的儿童的入学率。 在我们的机构里， 导致整个国家年龄< 2岁的组群的登记， 建立安全性和生物利用度，并促进后续 增加试验剂量。 我们预计将提供额外的 在这个关键的年龄范围内，在较高的药物剂量下， 本试验成功完成后，将开展一项疗效试验， 阿德福韦酯在儿童。 阿德福韦是第一种抗艾滋病药物 目标是在儿童中进行早期试验，同时在成人中进行试验。 有必要在儿童中进行早期试验，以解决 相对于成人，儿童中的抗艾滋病毒药物（3对10种可用药物 （1996年）。 阿德福韦酯目前在成人中进行早期试验， 与蛋白酶抑制剂组合产生“鸡尾酒”。 儿科 不久将进行审判。 阿德福韦可能改善儿童艾滋病毒 护理，提供更多的选择“儿科鸡尾酒”对抗艾滋病毒。 的 这种药物对巨细胞病毒具有很好的活性，巨细胞病毒是一种艾滋病病毒的共同病原体， 孩子们，使其具有双重吸引力。

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 institution resulted in enrollment of the entire national age < 2 yrs cohort, establishing safety and bioavailability, and promoting subsequent escalation in dosage of the trial. We anticipate providing additional representation in this 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.