The Metabolic Effects of Protease Inhibitors in HIV Infected Children
2005年6月23日 更新者:National Center for Research Resources (NCRR)
The use of protease inhibitors is increasing in HIV-infected children because this treatment has resulted in improved body weight, improved immune status and less hospitalizations.
However, recent reports suggest that these drugs may also be associated with some negative side-effects, specifically a syndrome of diabetes and fat redistribution.
Development of the fat redistribution/diabetes syndrome has recently been reported in HIV-infected children, as well as in adults.
Diabetes is associated with complications such as increased heart disease, eye disease and loss of kidney function.
Thus development of diabetes is a significant problem which could outweigh the benefits obtained by treating patients with protease inhibitors.
One major cause of diabetes is lack of normal response to insulin (insulin resistance).
Insulin resistance tends to be worse in family members where one or more parent has diabetes, and is also worse in certain ethnic groups.
The first major purpose of our study is measure insulin resistance in HIV-infected children who do not take protease inhibitors, and compare our findings to those from patients who are treated with protease inhibitors.
We will also follow patients newly treated with protease inhibitors for two years to evaluate changes in insulin sensitivity.
These results will be correlated with each patient's family history of diabetes and with ethnicity, and should help us better predict which children are "at risk" for development of diabetes from protease inhibitor therapy.
Children with HIV infection often have problems with gaining enough weight and with poor linear growth (height).
One likely reason for this is the way their bodies use and store protein.
The second purpose of our study is measure protein turnover and to correlate our findings with growth data.
We also plan to study the effects of protease inhibitor therapy on protein turnover.
We believe that these studies will provide knowledge to help clinicians formulate recommendations for nutritional and medical therapy.
研究概览
研究类型
介入性
阶段
- 不适用
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
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Texas
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Houston、Texas、美国、77030
- University of Texas Medical School, Dept. of Pediatrics
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Utah
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Salt Lake City、Utah、美国、84132
- University of Utah
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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
7年 至 18年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Inclusion criteria for HIV infected children- a) The participants may be either antiretroviral treatment naive, or experienced. Those individuals who are experienced will be treated with at least one new drug in addition to the protease inhibitor. The selection of the new antiretroviral regimen will be directed by a review of the patient's previous drug treatment history and/or the genetic or phenotypic characteristics of the patient's virus; b) We will recruit subjects from all CDC categories. Disease severity will subsequently be analyzed as a covariate; c) There will be no height, weight or other anthropometric inclusion criterion (these factors will be analyzed as covariates); d) All subjects will be studied when they have not had an acute superinfection for at least four weeks.
- Inclusion criteria for controls- Control volunteers will be normal healthy children who are matched to the HIV infected population for age, weight and race. Normal health and non-HIV infected status will be determined by history and by medical record review. Ethical considerations preclude HIV testing in normal children. Separate informed consent and assent forms will be utilized for the control and HIV population.
Exclusion Criteria:
- Exclusion criteria for HIV infected children- Use of Megace@ or another progestational agent, use of anabolic steroids, acute superinfection
- Exclusion criteria for controls- Previous medical history of any chronic disease or glucocorticoid use in the last six weeks. Adopted children who have no knowledge of family history.
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
- 主要用途:预防
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。
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
2022年12月7日
初级完成
2022年12月7日
研究完成
2022年12月7日
研究注册日期
首次提交
2000年2月29日
首先提交符合 QC 标准的
2000年2月29日
首次发布 (估计)
2000年3月1日
研究记录更新
最后更新发布 (估计)
2005年6月24日
上次提交的符合 QC 标准的更新
2005年6月23日
最后验证
2003年12月1日
更多信息
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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