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ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV, AIDS
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
HIV infection.
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
None
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Advanced Information
| 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 | |||
| 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 |
| |||
| Intervention | Other: non-interventional trial
No study specific intervention, non-interventional trial | |||
| Study Groups/Cohorts |
| |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| 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: None | |||
| Sex/Gender |
| |||
| Ages | 18 Years and older (Adult, Older Adult) | |||
| 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 |
| |||
| Investigators |
| |||
| PRS Account | ViiV Healthcare | |||
| Verification Date | April 2015 | |||