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

基于双 PI 的 HAART 方案与多 NRTI ART 方案，PACTG P1053

基本信息

批准号：
7607899
负责人：
Sharon A Nachman
金额：
$ 0.57万
依托单位：
STATE UNIVERSITY NEW YORK STONY BROOK
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-03-23 至 2007-11-30
项目状态：
已结题

项目摘要

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.

该子项目是利用该技术的众多研究子项目之一资源由 NIH/NCRR 资助的中心拨款提供。子项目及研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金，因此可以在其他 CRISP 条目中表示。列出的机构是中心，不一定是研究者的机构。抗艾滋病毒药物根据其作用原理进行分组 - 这些组称为类别。医生建议联合服用至少两种不同类别的三种抗艾滋病毒药物。然而，我们不知道哪种抗艾滋病毒药物组合最适合儿童/青少年，因为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。这项研究将探讨仅一类四种抗艾滋病毒药物的组合是否以及两类四种抗艾滋病毒药物的组合是否有效。我们认为，四种抗艾滋病药物的组合对于过去服用过多种抗艾滋病药物的儿童来说效果更好。然而，服用四种抗艾滋病毒药物可能会带来更多风险。这些风险在“本研究有哪些风险？”中进行了更多讨论。本同意书的部分。我们不知道四种抗艾滋病毒药物是否会比三种药物效果更好。本研究中使用的三种抗 HIV 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（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 HIV 药物，称为蛋白酶抑制剂 (PI) 和核苷逆转录酶抑制剂 (NRTI)。最后一种组合仅包含 NRTI 类抗 HIV 药物。替诺福韦、沙奎那韦和恩曲他滨已被 FDA 批准用于感染 HIV 的成人，但尚未批准用于感染 HIV 的儿童。其他抗艾滋病毒药物已获得 FDA 批准用于感染艾滋病毒的儿童。我们将研究您/您孩子的免疫系统对这些药物的反应如何。我们还将研究这些药物的安全性，以及您/您的孩子对这些药物的耐受程度。其中一种药物 - 替诺福韦 - 可能会降低骨矿物质密度（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矿物质密度降低。替诺福韦似乎对成人骨矿物质密度没有太大影响，但对儿童可能有更大的影响。我们将比较包含替诺福韦的组合与不包含替诺福韦的组合。