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Kaiser Permanente HIV Cohort Study

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Kaiser Permanente
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01339403
First received: March 16, 2011
Last updated: April 29, 2013
Last verified: April 2013
History of Changes

March 16, 2011
April 29, 2013
September 2008
May 2013   (final data collection date for primary outcome measure)
  • Incidence rate of Malignancies [ Time Frame: Mean follow up of 4 years ] [ Designated as safety issue: Yes ]
  • Incidence rate of Myocardial infarction [ Time Frame: Mean follow up of 4 years ] [ Designated as safety issue: Yes ]
  • Incidence rate of Myocardial ischemia [ Time Frame: Mean follow up of 4 years ] [ Designated as safety issue: Yes ]
  • Incidence rate of AIDS defining opportunistic infections [ Time Frame: Mean follow up of 4 years ] [ Designated as safety issue: Yes ]
  • Incidence rate of Liver failure [ Time Frame: Mean follow up of 4 years ] [ Designated as safety issue: Yes ]
  • Incidence rate of Liver related death [ Time Frame: Mean follow up of 4 years ] [ Designated as safety issue: Yes ]
  • Incidence rate of Rhabdomyolysis [ Time Frame: Mean follow up of 4 years ] [ Designated as safety issue: Yes ]
  • Incidence rate of All cause mortality [ Time Frame: Mean follow up of 4 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01339403 on ClinicalTrials.gov Archive Site
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Kaiser Permanente HIV Cohort Study
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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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
  • HIV
  • AIDS
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  • HIV infected
    No study specific intervention, non-interventional trial
  • HIV-uninfected
    No study specific intervention, non-interventional trial
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
225000
May 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

HIV infection.

Exclusion Criteria:

None
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01339403
A4001105
No
ViiV Healthcare
ViiV Healthcare
  • Kaiser Permanente
  • Pfizer
Study Director: Pfizer CT.gov Call Center Pfizer
ViiV Healthcare
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP