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的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得主要资金， 因此可以在其他CRISP条目中表示。所列机构为 中心，不一定是研究者的机构。 本研究是一项随机、比较反应的研究，对2-17岁严重免疫功能低下并正在开始高效抗逆转录病毒治疗（HAART）的HIV感染儿童进行长期随访。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拷贝数下降>0.75 log。它将由两组约90名受试者组成。本研究的目的是评估新衍生的CD 4 T细胞自发产生对回忆抗原（破伤风类毒素）的淋巴增殖反应的能力，或在破伤风疫苗加强接种后产生反应的能力;评估使用一系列甲型肝炎疫苗接种产生对T细胞依赖性抗原的保护性抗体反应的能力。并测量在最后一次接种疫苗之后的任何反应的持久性。 这项研究的基本原理是，艾滋病毒感染的儿童开始HAART已显示出显着抑制艾滋病毒的生长和显着增加的CD 4 T细胞计数。目前尚不清楚这一儿童群体中CD 4计数的增加在多大程度上转化为完全的功能性免疫恢复。感染艾滋病毒的儿童通常对常规儿童免疫接种表现出不良的血清学反应。本研究将检查HAART启动后再生的T细胞的表型，并通过评价T细胞对新抗原和回忆抗原的应答来评估功能。将检测对环境抗原（念珠菌）、回忆抗原（破伤风）和主要免疫原（甲型肝炎）的细胞介导的免疫应答。将评估免疫功能和恢复的研究，并将其与CD 4细胞、HAART治疗和缓解持续时间相关联。

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.