Kaiser Permanente HIV Cohort Study

NCT01339403

Last updated date
Contact
1-800-718-1021

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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
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
  • HIV
  • AIDS
Intervention Other: non-interventional trial
No study specific intervention, non-interventional trial
Study Groups/Cohorts
  • HIV infected
    No study specific intervention, non-interventional trial
    Intervention: Other: non-interventional trial
  • HIV-uninfected
    No study specific intervention, non-interventional trial
    Intervention: Other: non-interventional trial
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
 (submitted: December 10, 2013)
282368
Original Estimated Enrollment
 (submitted: April 19, 2011)
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
Sexes Eligible for Study:All
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
  • Kaiser Permanente
  • Pfizer
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account ViiV Healthcare
Verification Date April 2015