PACTG 1006: EFFECTS OF HAART ON THE RECOVERY OF IMMUNE FUNCTION IN HIV+ CHILDREN

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。 这项研究是一项随机的比较反应研究，对2-17岁的HIV感染儿童进行长期随访，这些儿童免疫功能严重受损，正在开始高效抗逆转录病毒治疗(HAART)。受试者必须是病毒学应答者，定义为HAART开始后1个月血浆HIV RNA拷贝数减少0.75log。它将由两组约90名受试者组成。这项研究的目的是评估新获得的CD4T细胞对召回抗原破伤风类毒素自发产生淋巴增殖反应的能力，或在用破伤风疫苗加强接种后产生反应的能力；评估使用一系列初级甲型肝炎疫苗对T细胞依赖抗原产生保护性抗体反应的能力；以及测量最后一次接种后任何反应的持久性。 这项研究的基本原理是，开始HAART的HIV感染儿童已经表现出对HIV生长的显著抑制和CD4T细胞计数的显著增加。目前尚不清楚这群儿童中CD4计数的增加在多大程度上可以转化为完全的功能免疫恢复。感染艾滋病毒的儿童通常对儿童常规免疫表现出较差的血清学反应。这项研究将检测HAART启动后再生的T细胞的表型，并将通过评估T细胞对新抗原和召回抗原的反应来评估其功能。将测试细胞对环境抗原(念珠菌)、召回抗原(破伤风)和主要免疫原(甲型肝炎)的免疫反应。免疫功能和恢复的研究将被评估，并与CD4细胞、HAART治疗和应答持续时间相关。

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. This study is a randomized, comparative response study with long-term follow-up in HIV-infected children aged 2-17 years who are severely immunocompromised and are initiating highly active antiretroviral therapy (HAART). Subjects must be virologic responders, defined as >0.75 log decrease in plasma HIV RNA copy number 1 month after initiation of HAART. It will consist of approximately 90 subjects in two groups. The purpose of this study is to assess the ability of newly derived CD4 T cells to spontaneously develop lymphoproliferative responses to a recall antigen, tetanus toxoid, or to develop responses after booster vaccinations with tetanus vaccine; to assess the ability to develop protective antibody responses to a T cell-dependent antigen using a primary series of hepatitis A vaccinations.; and to measure the durability of any response beyond the last vaccination. The rationale for this study is that HIV-infected children initiating HAART have shown significant inhibition of HIV growth and significant increases in CD4 T cell counts. It is not known to what extent an increase in CD4 count in this population of children translates to a complete functional immune recovery. HIV-infected children have typically demonstrated poor serological responses to routine childhood immunizations. This study will examine the phenotype of T cells regenerated post-HAART initiation and will assess function by evaluating T cell responses to neoantigens and recall antigens. Cell-mediated immune responses to an environmental antigen (Candida), a recall antigen (tetanus), and a primary immunogen (hepatitis A) will be tested. Studies of immunologic function and recovery will be assessed and correlated with CD4 cells, HAART treatment, and duration of response.