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临床试验/NCT00000955
NCT00000955已完成不适用

Two-Stage Tuberculin (PPD) Skin Testing in Individuals With Human Immunodeficiency Virus (HIV) Infection

National Institute of Allergy and Infectious Diseases (NIAID)14 个研究点 分布在 1 个国家目标入组 864 人开始时间: 2001年8月31日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
864
试验地点
14
主要终点
To estimate the percentage of HIV-infected individuals who demonstrate the booster effect

研究概览

简要总结

To quantitate in an HIV-infected population the percentage of patients demonstrating the "booster" phenomenon (attainment of a positive response to a second tuberculin purified protein derivative skin test when the first skin test was negative); to determine the relationship between the booster phenomenon and CD4-positive lymphocyte cell counts; to detect any relationship between the booster phenomenon and HIV exposure category.

The accuracy of skin testing to detect Mycobacterium tuberculosis (MTb) infection is dependent upon the host's ability to mount a delayed-type hypersensitivity (DTH) reaction; however, the DTH response may be impaired or absent in patients with impaired cell-mediated immunity, a classic characteristic of HIV infection. Patients in whom immunity is diminished, but not absent, may test negative the first time a purified protein derivative skin test for MTb is administered, but if the same skin test is repeated, a positive DTH response may then be elicited. This occurrence is known as the "booster" phenomenon.

详细描述

The accuracy of skin testing to detect Mycobacterium tuberculosis (MTb) infection is dependent upon the host's ability to mount a delayed-type hypersensitivity (DTH) reaction; however, the DTH response may be impaired or absent in patients with impaired cell-mediated immunity, a classic characteristic of HIV infection. Patients in whom immunity is diminished, but not absent, may test negative the first time a purified protein derivative skin test for MTb is administered, but if the same skin test is repeated, a positive DTH response may then be elicited. This occurrence is known as the "booster" phenomenon.

Patients who have had a negative purified protein derivative (PPD) skin test for M. tuberculosis within 7-28 days prior to study entry will receive a second PPD test by the Mantoux method (5 TU intradermally to the volar aspect of the forearm). Skin tests will be read 48-72 hours after application. Patients with a positive skin test (defined as an induration, or small hard knot, of 5 mm or greater forming beneath the skin) will be referred to their primary physicians for further evaluation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
13 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

A

Other

All eligible study participants

干预措施: Tuberculin Purified Protein Derivative (Drug)

结局指标

主要结局

To estimate the percentage of HIV-infected individuals who demonstrate the booster effect

时间窗: Throughout study

次要结局

  • To determine the relationship of induration size after the first PPD skin test to that after the second PPD skin test(After the second PPD skin test)
  • To determine the relationship of boosting to CD4+ cell counts, HIV exposure categories, demographics, and TB risk categories(Throughout study)
  • To determine the relationships among the booster effect, CD4+ cell count, and other HIV-related patient characteristics(Throughout study)

研究者

研究点 (14)

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