p24 Antigen and Alternative Markers in Infants, Vietnam

描述（由申请人提供）：艾滋病毒的流行正在越南迅速展开。越来越多的感染艾滋病毒的婴儿和儿童获得诊断检测和预防性临床干预的机会有限。在这种情况下，最小的儿科艾滋病毒研究基础设施存在，在越南的儿科艾滋病毒感染的流行病学研究和早期诊断检测和监测算法的评价将建立必要的基线数据，从其中开发后续的研究干预措施。 本申请的总体目标是支持主要研究者发展成为儿科HIV流行病学的独立临床研究者。为了实现这一目标，拟议的方案包括培训和科学两个部分。该申请的培训部分包括完成公共卫生硕士学位课程，该课程将提供研究设计，流行病学方法和生物统计学方面的正式培训，重点是国际卫生和政策问题。一个多元化的导师小组将促进临床和研究经验，将指导职业发展。 该应用程序的科学组成部分测试的假设，即“超灵敏”热解离信号放大p24抗原检测是一个敏感和特异性的替代标准DNA PCR诊断艾滋病毒在越南的儿科暴露的婴儿。此外，在这些更容易获得的标志物与HIV感染婴儿的临床疾病进展相似的假设下，将替代（“第二级”）替代实验室标志物（包括总淋巴细胞计数、p24抗原水平、红细胞压积/血红蛋白和白蛋白）与CD 4和RNA病毒载量进行比较。这些假设将在胡志明市围产期暴露婴儿的前瞻性队列研究中进行检验。婴儿将定期接受临床评估和质量控制实验室检测，以进行诊断和监测。主要研究者将在胡志明市花费较长的研究时间进行研究。将进行描述性、单变量和多变量分析，以比较实验室结果和临床结局。这项研究的结果可能会导致越南更广泛地获得艾滋病毒诊断检测，并为未来的儿科护理和治疗计划开发可行的实验室监测算法。

DESCRIPTION (provided by applicant): The HIV epidemic is rapidly unfolding in Vietnam. The growing group of HIV-infected infants and children has limited access to diagnostic testing and preventive clinical interventions. In this setting where minimal pediatric HIV research infrastructure exists, a study of the epidemiology of pediatric HIV infection in Vietnam and evaluations of early diagnostic testing and monitoring algorithms would establish the necessary baseline data from which to develop subsequent research interventions. The overall objective of this application is to support the principal investigator's development into an independent clinical researcher in pediatric HIV epidemiology. To accomplish this objective, the proposed program has both training and scientific components. The training component of this application includes completion of a Master of Public Health degree program that will provide formal training in study design, epidemiologic methods, and biostatistics, with a focus on international health and policy issues. A diverse group of mentors will facilitate clinical and research experiences that will guide career development. The scientific component of this application tests the hypothesis that the "ultrasensitive" heat-dissociated signal-amplified p24 antigen assay is a sensitive and specific alternative to standard DNA PCR for diagnosing HIV in pednatally-exposed infants in Vietnam. In addition, alternative ("second tier") surrogate laboratory markers - including total lymphocyte count, p24 antigen levels, hematocrit/hemoglobin, and albumin - will be compared to CD4 and RNA viral load, under the hypothesis that these more easily accessible markers are similady associated with clinical disease progression in HIV-infected infants. These hypotheses will be tested in the context of a prospective cohort study of perinatally-exposed infants in Ho Chi Minh City. Infants will have regularly scheduled clinical evaluations and quality-controlled laboratory testing for diagnosis and monitoring. The principal investigator will spend extended research time in Ho Chi Minh City to conduct the study. Descriptive, univariate, and multivariate analyses will be performed to compare laboratory results and clinical outcomes. The findings of this study may result in more widespread access to HIV diagnostic testing in Vietnam, and the development of feasible laboratory monitoring algorithms for future pediatric care and treatment programs.