A DUAL PI-BASED HAART REGIMEN VS A MULTI-NRTI ART REGIMEN, PACTG P1053

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 抗艾滋病毒药物根据它们的作用方式进行分类--这些分组被称为类别。医生建议服用至少两种不同类别的三种抗艾滋病毒药物的组合。然而，我们不知道哪些抗艾滋病毒药物的组合对儿童/青少年最有效，他们已经服用了许多不同的抗艾滋病毒药物，但仍无法控制血液中的艾滋病毒。 这项研究将观察只来自一类的四种抗艾滋病毒药物的组合是否像来自两类的四种抗艾滋病毒药物的组合一样有效。我们认为，对于过去服用过许多抗艾滋病毒药物的儿童来说，四种抗艾滋病毒药物的组合将更有效。然而，服用四种抗艾滋病毒药物可能会有更多风险。这些风险在“这项研究的风险是什么？”中有更多的讨论。此同意书的一部分。我们不知道四种抗艾滋病毒药物是否会比三种效果更好。 这项研究中使用的三种抗艾滋病毒药物组合是： “洛匹那韦/利托那韦+沙奎那韦+恩曲他滨+阿巴卡韦(第1A组)” “洛匹那韦/利托那韦+沙奎那韦+恩曲他滨+替诺福韦(1B组)” 阿巴卡韦+拉米夫定+齐多夫定+替诺福韦(第2组) 前两种组合包括两类抗艾滋病毒药物，称为蛋白酶抑制剂(PI)和核苷逆转录酶抑制剂(NRTI)。最后一种组合只包括来自NRTI类别的抗艾滋病毒药物。 替诺福韦、沙奎那韦和恩曲他滨已被FDA批准用于感染艾滋病毒的成人，但尚未被批准用于感染艾滋病毒的儿童。FDA批准其他抗艾滋病毒药物用于感染艾滋病毒的儿童。 我们将看看您/您孩子的免疫系统对这些药物的反应如何。我们还将观察这些药物的安全性，以及您/您的孩子对这些药物的耐受性(S)。其中一种药物-替诺福韦-可能会降低骨密度(骨骼的密度或坚固程度)。在一些动物研究中，替诺福韦治疗导致骨密度降低。替诺福韦似乎对成人的骨密度没有太大影响，但它可能对儿童有更大的影响。我们将比较包含替诺福韦的组合和不包含替诺福韦的组合。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Anti-HIV medicines are grouped according to how they work - these groups are called classes. Doctors recommend taking a combination of three anti-HIV medicines from at least two different classes. However, we do not know what combinations of anti-HIV medicines will work best for children/adolescents who have been on many different anti-HIV medicines that are still unable to control the HIV in the blood. This study will see if a combination of four anti-HIV medicines from only one class works as well as a combination of four anti-HIV medicines from two classes. We think that a combination of four anti-HIV medicines will work better for children who have taken many anti-HIV medicines in the past. However, there may be more risks associated with taking four anti-HIV medicines. These risks are discussed more in the "What Are the Risks of This Study?" section of this consent form. We do not know if four anti-HIV medicines will work better than three. The three combinations of anti-HIV medicines used in this study are: " lopinavir/ritonavir + saquinavir + emtricitabine + abacavir (Group 1A) " lopinavir/ritonavir + saquinavir + emtricitabine + tenofovir (Group 1B) " abacavir + lamivudine + zidovudine + tenofovir (Group 2) The first two combinations include anti-HIV medicines from 2 classes, called protease inhibitors (PIs) and nucleoside reverse transcriptase inhibitors (NRTIs). The last combination includes anti-HIV medicines only from the NRTI class. Tenofovir, saquinavir, and emtricitabine are approved by the FDA for use in HIV-infected adults, but have not been approved for use in HIV-infected children. The other anti-HIV medicines are approved by the FDA for use in HIV-infected children. We will look at how well your/your child's immune system responds to these medicines. We will also look at how safe these medicines are, and how well you/your child tolerate(s) these medicines. One of the medicines - tenofovir - may decrease bone mineral density (how dense, or solid, the bones are). In some animal studies, treatment with tenofovir resulted in lower bone mineral density. Tenofovir does not appear to have much effect on bone mineral density in adults, but it may have more of an effect in children. We will compare the combinations that include tenofovir with the combinations that do not include tenofovir.