Kaiser Permanente HIV Cohort Study
2015年4月2日 更新者:ViiV Healthcare
Hiv Infection, Antiretroviral Therapy Use And Other Predictors Of Selected Clinical Events In Kaiser Permanente
Human Immunodeficiency Virus (HIV) infected patients in the Kaiser Permanente HIV registry wil be followed in the usual clinical care to estimate the rates of specified clinical events.
The rates will be stratified by relevant characteristics like age, CD4 counts, HIV Viral Load (VL), HIV medication history.
The rates in the HIV infected cohort wil be compared with the rates of these events in patients in the Kaiser Permanente database who are not infected with HIV.
研究概览
详细说明
All HIV infected patients in the database will be included without any sampling.
A random sample of non-HIV infected patients will be included as comparator.
研究类型
观察性的
注册 (实际的)
282368
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
取样方法
非概率样本
研究人群
HIV infected patients in the HIV Registry of Kasier Permanente Northern and Southern California and a matched cohort of non-HIV infected patients in Kaiser Permanente
描述
Inclusion Criteria:
HIV infection.
Exclusion Criteria:
None
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
队列和干预
团体/队列 |
干预/治疗 |
---|---|
HIV infected
No study specific intervention, non-interventional trial
|
No study specific intervention, non-interventional trial
|
HIV-uninfected
No study specific intervention, non-interventional trial
|
No study specific intervention, non-interventional trial
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Incidence Rate of Malignancies
大体时间:Up to Week 835
|
Incidence rate of malignancies was calculated as the number of events divided by person-time.
Only the first diagnosis of each event per participant was included.Person-time was calculated as the sum of all time contributed by each individual who were Kaiser Permanente (KP) member from the date of HIV care initiation at that institution or January 1, 1996 for KP Northern California(KPNC) and January 1, 2000 for KP Southern California(KPSC) if in care prior to this date.
Malignancies included acquired immunodeficiency syndrome (AIDS)-defining malignancies and non-AIDS defining malignancies.AIDS-defining malignancies included invasive cervical cancer,invasive non-Hodgkin's lymphoma and kaposi's sarcoma;non-AIDS defining malignancies cancers ascertained from the KP cancer registries.Overall data for non-AIDS and AIDS defining malignancies, along with individual data for AIDS-defining malignancies was reported.
Incidence rate was computed as the number of events per 100,000 person-years.
|
Up to Week 835
|
Incidence Rate of Myocardial Infarction and Ischemia
大体时间:Up to Week 835
|
Incidence rate of cardiovascular (CVS)events including myocardial infarction (MI) and ischemia was calculated as the number of events divided by person-time.
Only the first diagnosis of each event per participant was included.
Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date.
Incidence rate was computed as the number of events per 100,000 person-years.
|
Up to Week 835
|
Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections
大体时间:Up to Week 835
|
Incidence rate of AIDS-defining opportunistic infections (OI) was calculated as the number of events divided by person-time.Only the first diagnosis of each event per participant was included.Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1,1996 for KPNC and January 1,2000 for KPSC if in care prior to this date.OI were those that occurred on immune-compromised participants.AIDS-defining infections included:wasting syndrome;pneumocystis jirovecii pneumonia;recurrent pneumonia;cytomegalovirus;HIV-related encephalopathy;esophageal candidiasis;mycobacterium avium complex;cryptococcosis;mycobacterium tuberculosis;progressive multifocal leukoencephalopathy;lung candidiasis;toxoplasmosis of brain;coccidiomycosis;histoplasmosis;recurrent salmonella septicemia;chronic isosporiasis;cryptosporidiosis.Incidence rate was computed as the number of events per 100,000 person-years.
|
Up to Week 835
|
Incidence Rate of Liver Failure
大体时间:Up to Week 835
|
Incidence rate of liver failure was calculated as the number of events divided by person-time.
Only the first diagnosis of each event per participant was included.
Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date.
Incidence rate was computed as the number of events per 100,000 person-years.
|
Up to Week 835
|
Incidence Rate of Liver Related Death
大体时间:Up to Week 835
|
Incidence rate of liver related death was calculated as the number of events divided by person-time.
Only the first diagnosis of each event per participant was included.
Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date.
Incidence rate was computed as the number of events per 100,000 person-years.
|
Up to Week 835
|
Incidence Rate of Rhabdomyolysis
大体时间:Up to Week 835
|
Incidence rate of Rhabdomyolysis was calculated as the number of events divided by person-time.
Only the first diagnosis of each event per participant was included.
Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date.
Incidence rate was computed as the number of events per 100,000 person-years.
|
Up to Week 835
|
Incidence Rate of All-Cause Mortality
大体时间:Up to Week 835
|
Incidence rate of all-cause mortality was calculated as the number of events divided by person-time.
Only the first diagnosis of each event per participant was included.
Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date.
Incidence rate was computed as the number of events per 100,000 person-years.
|
Up to Week 835
|
Incidence Rate of Viral Encephalitis
大体时间:Up to Week 730
|
Incidence rate of viral encephalitis (VE) was calculated as the number of events divided by person-time.
Only the first diagnosis of each event per participant was included.
Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date.
Incidence rate was computed as the number of events per 100,000 person-years.
The participants with viral encephalitis were followed-up up to 31st December 2009 (730 Weeks).
|
Up to Week 730
|
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。
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。
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
2009年2月1日
初级完成 (实际的)
2013年10月1日
研究完成 (实际的)
2013年10月1日
研究注册日期
首次提交
2011年3月16日
首先提交符合 QC 标准的
2011年4月19日
首次发布 (估计)
2011年4月20日
研究记录更新
最后更新发布 (估计)
2015年4月3日
上次提交的符合 QC 标准的更新
2015年4月2日
最后验证
2015年4月1日
更多信息
与本研究相关的术语
其他研究编号
- A4001105
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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