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临床试验/NCT02058927
NCT02058927已完成不适用

Immune Reconstitution to Measles Virus of HIV-1-Infected Zambian Children Initiating Antiretroviral Therapy

University of North Carolina, Chapel Hill1 个研究点 分布在 1 个国家目标入组 203 人开始时间: 2011年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
203
试验地点
1
主要终点
Memory immune responses to measles virus

研究概览

简要总结

This is an observational study of HIV-1 infected children starting antiretroviral therapy to measure the magnitude and quality of general immune reconstitution and pathogen-specific immune reconstitution to measles virus.

详细描述

This is a prospective, observational cohort study of 230 HIV-1-infected children initiating ART at public clinics in Lusaka, Zambia to measure the magnitude and quality of general immune reconstitution and pathogen-specific immune reconstitution to measles virus. Non-specific immune reconstitution will be assessed by serial measurements of the number and percentages of CD4+ and CD8+ T-lymphocytes, number and percentages of activated CD4+ and CD8+ T-lymphocytes (using cell surface staining for HLA-DR and CD38), changes in the proportions of naïve and memory CD4+ and CD8+ T-lymphocyte subsets (using cell surface staining for CD45RA and CCR7), and changes in thymic output as determined by TREC levels. Virologic responses to ART will be assessed by serial measurements of plasma HIV-1 RNA levels.

Within the observational study, there is a nested study of revaccination against measles virus of HIV-1-infected children receiving ART who lack protective antibody titers to assess the proportion of revaccinated children who develop protective immunity and the duration of protective immunity. Anti-measles virus IgG antibodies will be measured 9 months after initiation of ART. The results will be available at the 12-month follow-up visit and measles revaccination will be recommended to those children lacking protective antibody levels to measles virus.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
9 Months 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Boys and girls 9 months to 10 years of age residing in Lusaka, Zambia are eligible for enrolment.
  • initiating ART
  • history of measles vaccination confirmed by examination of the Immunization Card.

排除标准

  • 未提供

研究组 & 干预措施

HIV-1 infected children revaccinated

nested study of revaccination against measles virus of HIV-1-infected children receiving ART who lack protective antibody titers

干预措施: Measles vaccine (Drug)

结局指标

主要结局

Memory immune responses to measles virus

时间窗: 0, 6, 12, 24, 30 and 36 months from start of ART

Memory immune responses to measles virus will be measured to characterize the magnitude and quality of immune reconstitution in HIV-1 infected Zambian children initiating ART and determine pathogen-specific immune reconstitution.

次要结局

  • Humoral and cellular immune responses to measles virus before and after revaccination(12, 15, 24, 30 and 36 months from start of ART)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carolyn Bolton Moore, MD

Assistant Professor

University of North Carolina, Chapel Hill

研究点 (1)

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