Kaiser Permanente HIV Cohort Study
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ClinicalTrials.gov Identifier: NCT01339403 |
Recruitment Status
:
Completed
First Posted
: April 20, 2011
Results First Posted
: April 3, 2015
Last Update Posted
: April 3, 2015
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Sponsor:
ViiV Healthcare
Collaborators:
Kaiser Permanente
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
- Study Details
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- Study Results
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Tracking Information | ||||
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First Submitted Date | March 16, 2011 | |||
First Posted Date | April 20, 2011 | |||
Results First Submitted Date | October 27, 2014 | |||
Results First Posted Date | April 3, 2015 | |||
Last Update Posted Date | April 3, 2015 | |||
Study Start Date | February 2009 | |||
Actual Primary Completion Date | October 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
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Original Primary Outcome Measures |
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Change History | Complete list of historical versions of study NCT01339403 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures | Not Provided | |||
Original Secondary Outcome Measures | Not Provided | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Kaiser Permanente HIV Cohort Study | |||
Official Title | Hiv Infection, Antiretroviral Therapy Use And Other Predictors Of Selected Clinical Events In Kaiser Permanente | |||
Brief Summary | 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. | |||
Detailed Description | 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. | |||
Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | 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 | |||
Condition |
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Intervention | Other: non-interventional trial
No study specific intervention, non-interventional trial |
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Study Groups/Cohorts |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
282368 | |||
Original Estimated Enrollment |
225000 | |||
Actual Study Completion Date | October 2013 | |||
Actual Primary Completion Date | October 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria: HIV infection. Exclusion Criteria: |
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01339403 | |||
Other Study ID Numbers | A4001105 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | ViiV Healthcare | |||
Study Sponsor | ViiV Healthcare | |||
Collaborators |
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Investigators |
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PRS Account | ViiV Healthcare | |||
Verification Date | April 2015 |