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临床试验/NCT00100542
NCT00100542已完成不适用

Psychiatric Co-Morbidity in Perinatally HIV-Infected Children and Adolescents

International Maternal Pediatric Adolescent AIDS Clinical Trials Group32 个研究点 分布在 2 个国家目标入组 800 人开始时间: 2005年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
800
试验地点
32

研究概览

简要总结

The purpose of this study is to determine whether HIV and anti-HIV drugs cause mental health problems or make mental health problems worse in children and adolescents who were infected with HIV at birth.

详细描述

Research has shown that HIV is able to penetrate the blood-brain barrier and may significantly affect the central nervous system (CNS). Although the effects of HIV on the CNS are not fully understood, there is growing evidence that the effects are psychosocial in nature; HIV infected children experience higher rates of psychiatric symptoms and hospitalizations than their uninfected counterparts. Confounding the HIV CNS relationship is evidence suggesting that the CNS effects of HIV may also be related to antiretroviral treatment. This study will examine the rates and severity of psychiatric symptoms in both HIV infected and uninfected children and adolescents. In addition, this study will determine the relationship between duration of antiretroviral treatment and psychiatric symptoms.

No treatment will be given as part of this study. The study will last for 96 weeks and be divided into two parts. In Part 1, HIV infected and uninfected participants and their caregivers will complete a series of measures and questionnaires regarding mental health, pain, and adherence to treatment. In Part 2, all participants and their caregivers will complete a subset of the original measures at Weeks 48 and 96. This follow-up part of the study will assess any long-term changes in psychiatric symptoms. In addition, a subset of HIV infected and uninfected participants and their caregivers will take part in psychiatric interviews at specified study sites. A portion of these interviews will be audio-taped.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
6 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究者

发起方
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
申办方类型
Network

研究点 (32)

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