ACTG 265

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。265这项试验的假设是，水痘减毒活疫苗对1-8岁的VZV幼稚、无症状或轻微症状的HIV感染儿童是安全的。本研究旨在评价HIV感染儿童接种水痘疫苗的安全性和免疫原性。这项研究将监测接种水痘减毒活疫苗后的短期局部和全身反应，以及接种水痘疫苗的儿童艾滋病毒的临床和免疫学进展。研究人群由1至8岁的未感染VZV的儿童组成，他们属于三个治疗组之一：(1)无症状或轻度症状队列：I组(完全缓解)；(2)有症状队列：II组：B1、A2、N2或B2类受试者；(3)有症状队列：III组：先前被归类为免疫学阶段3的受试者，但在进入时和进入前3个月处于A1或N1类。此外，受试者必须在进入试验前至少三个月接受稳定的抗逆转录病毒治疗(方案必须包括至少一次PI和2次RTI)。研究人群还包括一组对照组，由无症状或轻度症状组组成，其中包括在过去12个月内有野生型水痘感染的N1或A1类围产期获得艾滋病毒-1感染的儿童(应计完成)。共有127名受试者(无症状队列：I组n=48；对照组n=19[完全应计]；有症状队列：II组n=30；III组n=30)入选。这项研究在全国范围内招募了129名患者。我们在这项研究中招募了3名患者。

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. ABSTRACT 265 The hypothesis of this trial is that live-attenuated varicella vaccine will be safe in VZV-naive, asymptomatic or mildly symptomatic HIV-infected children 1-8 years of age. The aim of this study is to evaluate the safety and immunogenicity of varicella vaccine in HIV infected children. The study will monitor the short-term local and systemic reactions following administration of live-attenuated varicella vaccine, and the clinical and immunologic progression of HIV in children who have received varicella vaccine. The study population is composed of VZV-naive children between 1 and 8 years of age who fall into one of three treatment groups: (1) asymptomatic or mildly symptomatic cohort: Group I (accrual complete); (2) symptomatic cohort: Group II: category B1, A2, N2 or B2 subjects; (3) symptomatic cohort: Group III: subjects previously classified at immunologic stage 3, but are at category A1 or N1 at entry and for three months prior to entry. Additionally, subjects must have been on stable antiretroviral therapy for at least three months prior to entry, (regimen must include at least one PI and > 2 RTIs). The study population also includes a control group consisting of asymptomatic or mildly symptomatic group consisting of children with category N1 or A1 perinatally-acquired HIV-1 infection who have had wild-type varicella infection in the past 12 months (accrual complete). A total of 127 (asymptomatic cohort: Group I n=48; control n=19 [accrual complete]; symptomatic cohort: Group II n=30; Group III n=30) subjects will be enrolled. The study has enrolled 129 patients nationally. We have enrolled 3 patients in this study.