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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
  Purpose

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.


Condition Phase
HIV
AIDS
 Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: HIV Infection, Antiretroviral Therapy Use and Other Predictors of Selected Clinical Events in Kaiser Permanente

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 225000
Study Start Date: September 2008
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
HIV infected
No study specific intervention, non-interventional trial
HIV-uninfected
No study specific intervention, non-interventional trial

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

Criteria

Inclusion Criteria:

HIV infection.

Exclusion Criteria:

None

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01339403

Sponsors and Collaborators
ViiV Healthcare
Kaiser Permanente
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT01339403     History of Changes
Other Study ID Numbers: A4001105
Study First Received: March 16, 2011
Last Updated: April 29, 2013
Health Authority: United States: Investigational Review Board

ClinicalTrials.gov processed this record on May 21, 2013