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Effects of Anti-HIV Therapy on Nervous System Function

2014年4月16日 更新者：National Institute of Allergy and Infectious Diseases (NIAID)

Neurology: A Substudy of a Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (SMART) to Determine the Impact of the Strategies Upon Central and Peripheral Nervous System Function

The purpose of this study is to observe the way two different anti-HIV treatment strategies affect nerve and brain function in adults with HIV.

研究概览

地位

完全的

条件

详细说明

AIDS dementia complex (ADC) is a condition characterized by cognitive impairment, psychomotor slowing, and behavioral change. A milder form of ADC, called HIV minor cognitive/motor disorder (MCMD), is characterized by similar symptoms but has less of an impact on daily functioning. The neurocognitive impairment that results from ADC and MCMD carries an increased risk of poor drug adherence, morbidity, and mortality. It is unclear if highly active antiretroviral therapy (HAART) is effective in preserving neurocognitive function or in preventing or treating neurocognitive impairment. Distal symmetric sensory polyneuropathy (DSPN) and nucleoside-related neuropathy are two other serious conditions that HIV patients are at high risk for. DSPN is thought to be caused by active HIV infection; nucleoside-related neuropathy is thought to be caused by mitochondrial toxicity related to the use of certain antiretrovirals. These 2 conditions may lead to severe pain and discomfort in the feet. It is unknown what connection, if any, there is between DSPN and nucleoside-related neuropathy and the use of HAART. More data are needed on the natural history of these conditions.

This trial is a substudy of a study of management of antiretroviral therapy (SMART). In the SMART study, patients will participate in one of two strategies: a drug conservation (DC) strategy and a viral suppression (VS) strategy. Participants in the DC group will stop or defer HAART, then receive episodic HAART treatment for the minimum time needed to maintain a CD4 cell count of at least 250 cells/mm3. Participants in the VS group will receive HAART to maintain a viral load as low as possible, regardless of CD4 count. The purpose of this study is to compare changes in neurocognitive functioning and peripheral neuropathy symptoms between the 2 strategies of the SMART study.

Patients will participate in this substudy and the main SMART study at the same time. Within 45 days prior to randomization into the main SMART study, participants will have baseline data collected for this substudy. This data will include peripheral neuropathy assessments, treatments for symptoms of peripheral neuropathy. At selected study sites, additional measures will assess neurocognitive function, depression, alcohol and drug use, and education. At 6 months, 12 months, and every 12 months thereafter, peripheral neuropathy symptoms and treatment for the symptoms will be assessed; a pain questionnaire will also be completed. Participants will be followed until the SMART study ends.

研究类型

观察性的

注册 (实际的)

297

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 加拿大
    • Nova Scotia
      • Halifax、Nova Scotia、加拿大、B3H 2Y9
        • Q.E. II Health Sciences Ctr., Captial District Authority, Victoria Gen. Hosp. CRS
    • Ontario
      • Windsor、Ontario、加拿大、N8W 1E3
        • Windsor Regional Hosp., HIV Care Program CRS
  • 巴西
      • Sao Paulo、巴西、01246-900
        • Instituto de Infectologia Emilio Ribas CRS
    • Bahia
      • Salvador、Bahia、巴西、40110-160
        • Hosp. Universitario Prof. Edgard SantosCRS
  • 泰国
      • Chiang Mai、泰国
        • Sanpatong Hosp. CRS
      • Khon Kaen、泰国、40002
        • Khon Kaen Univ., Srinagarind Hosp., Div. of Infectious Diseases & Tropical Medicine, Dept. of Medici
    • Nonthaburi
      • Muang、Nonthaburi、泰国
        • Bamrasnaradura Institute CRS
    • Ratchathewi
      • Bangkok、Ratchathewi、泰国
        • Chulalongkorn University Hospital CRS
      • Bangkok、Ratchathewi、泰国
        • Mahidol Univ., Ramathibodi Hosp., Div of Infectious Disease CRS
  • 澳大利亚
    • New South Wales
      • Burwood、New South Wales、澳大利亚、2134
        • Burwood Road Gen. Practice CRS
      • Darlinghurst、New South Wales、澳大利亚、2010
        • St. Vincent's Hospital CRS
      • Westmead、New South Wales、澳大利亚、2145
        • Westmead Hospital CRS
    • Victoria
      • Carlton,、Victoria、澳大利亚
        • Melbourne Sexual Health Ctr. CRS
      • Melbourne、Victoria、澳大利亚、3004
        • The Alfred Hosp., Clinical Research - Infectious Diseases Unit CRS
      • Melbourne、Victoria、澳大利亚、3181
        • Prahran Market Clinic CRS
  • 美国
    • California
      • San Francisco、California、美国、94114
        • Castro-Mission Health Ctr. CRS
    • Colorado
      • Denver、Colorado、美国、80204-4507
        • Univ. of Colorado Health Science Ctr. CRS
      • Denver、Colorado、美国、80205
        • Eastside Family Health Ctr. CRS
      • Denver、Colorado、美国、80204
        • Denver Public Health CRS
      • Denver、Colorado、美国、80204-4507
        • Kaiser Permanente of Denver CRS
      • Wheat Ridge、Colorado、美国、80033
        • Western Infectious Disease Consultants CRS
    • District of Columbia
      • Washington、District of Columbia、美国、20422
        • Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS
    • Florida
      • Jacksonville、Florida、美国、32206
        • Univ. of Florida, Div. of Infectious Diseases CRS
    • Louisiana
      • Baton Rouge、Louisiana、美国、70805
        • Earl K. Long Med. Ctr., LSU - Mid City EIC Clinic CRS
    • Michigan
      • Detroit、Michigan、美国、48202
        • Henry Ford Hosp. CRS
      • Detroit、Michigan、美国、48201
        • Wayne State Univ. CRS
      • Lansing、Michigan、美国、48910
        • Michigan State Univ., Infectious Disease Clinic CRS
    • New York
      • Bronx、New York、美国、10457
        • Bronx-Lebanon Hosp. Ctr. CRS
      • Bronx、New York、美国、10461
        • Jacobi Med. Ctr., Ambulatory Care Pavillion CRS
      • Bronx、New York、美国、10467
        • Montefiore Med. Ctr., AIDS Ctr. CRS
      • Bronx、New York、美国、10468
        • Bronx VAMC CRS
      • Brooklyn、New York、美国、11203
        • SUNY Downstate Med. Ctr., HIV Ctr. for Women & Children CRS
      • New York、New York、美国、10037-1802
        • Harlem Hospital Ctr./Columbia University CRS (Gordin CTU)
    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73104
        • Univ. of Oklahoma Health Sciences Ctr., Div. of Infectious Diseases CRS
    • Oregon
      • Portland、Oregon、美国、97227
        • Kaiser Immune Deficiency Clinic of Portland CRS
      • Portland、Oregon、美国、97239
        • Oregon Health & Sciences Univ. Internal Medicine (L-475) CRS
      • Portland、Oregon、美国、97210
        • The Research & Education Group-Portland CRS
      • Portland、Oregon、美国、97227
        • Legacy Clinic Emanuel CRS
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19140
        • Temple Univ. School of Medicine CRS
    • Virginia
      • Fredericksburg、Virginia、美国、22401
        • MediCorp, Infectious Disease Associates CRS
      • Richmond、Virginia、美国、23298
        • Virginia Commonwealth Univ. Medical Ctr. CRS
      • Richmond、Virginia、美国、23224
        • CrossOver Health Ctr. CRS
      • Richmond、Virginia、美国、23298
        • VCU Health Systems, Infectious Disease Clinic CRS
      • Richmond、Virginia、美国、23223
        • Vernon Harris East End Community Health Ctr. CRS
    • Wisconsin
      • Milwaukee、Wisconsin、美国、53226
        • Med. College of Wisconsin, Infectious Disease Clinic CRS

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Coenrollment in the SMART study

Exclusion Criteria:

  • Unable to comply with all study requirements

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

研究衡量的是什么？

主要结果指标

结果测量
Change in QNPZ-5 scores
time to development of symptomatic peripheral neuropathy
change in peripheral neuropathy symptoms

次要结果测量

结果测量
Time to neurocognitive impairment
time to development of ADC, stage 2 or greater
chage in peripheral neuropathy symptoms
time to development of asymptomatic or symptomatic peripheral neuropathy
time to resolution of symptomatic peripheral neuropathy

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

National Institute of Allergy and Infectious Diseases (NIAID)

调查人员

  • 学习椅：Edwina Wright, MBBS, FRACP、Infectious Disease Unit, the Alfred Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2005年3月1日

初级完成 (实际的)

2007年7月1日

研究完成 (实际的)

2007年7月1日

研究注册日期

首次提交

2007年2月5日

首先提交符合 QC 标准的

2007年2月5日

首次发布 (估计)

2007年2月6日

研究记录更新

最后更新发布 (估计)

2014年4月17日

上次提交的符合 QC 标准的更新

2014年4月16日

最后验证

2014年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CPCRA 065F
  • CPCRA 065
  • CPCRA 065F1
  • 10115 (DAIDS-ES)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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