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Kaiser Permanente HIV Cohort Study

This study has been completed.
Sponsor:
Collaborators:
Kaiser Permanente
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01339403
First received: March 16, 2011
Last updated: April 2, 2015
Last verified: April 2015
History of Changes

March 16, 2011
April 2, 2015
February 2009
October 2013   (final data collection date for primary outcome measure)
  • Incidence Rate of Malignancies [ Time Frame: Up to Week 835 ] [ Designated as safety issue: Yes ]
    Incidence rate of malignancies was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included.Person-time was calculated as the sum of all time contributed by each individual who were Kaiser Permanente (KP) member from the date of HIV care initiation at that institution or January 1, 1996 for KP Northern California(KPNC) and January 1, 2000 for KP Southern California(KPSC) if in care prior to this date. Malignancies included acquired immunodeficiency syndrome (AIDS)-defining malignancies and non-AIDS defining malignancies.AIDS-defining malignancies included invasive cervical cancer,invasive non-Hodgkin's lymphoma and kaposi's sarcoma;non-AIDS defining malignancies cancers ascertained from the KP cancer registries.Overall data for non-AIDS and AIDS defining malignancies, along with individual data for AIDS-defining malignancies was reported. Incidence rate was computed as the number of events per 100,000 person-years.
  • Incidence Rate of Myocardial Infarction and Ischemia [ Time Frame: Up to Week 835 ] [ Designated as safety issue: Yes ]
    Incidence rate of cardiovascular (CVS)events including myocardial infarction (MI) and ischemia was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years.
  • Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections [ Time Frame: Up to Week 835 ] [ Designated as safety issue: Yes ]
    Incidence rate of AIDS-defining opportunistic infections (OI) was calculated as the number of events divided by person-time.Only the first diagnosis of each event per participant was included.Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1,1996 for KPNC and January 1,2000 for KPSC if in care prior to this date.OI were those that occurred on immune-compromised participants.AIDS-defining infections included:wasting syndrome;pneumocystis jirovecii pneumonia;recurrent pneumonia;cytomegalovirus;HIV-related encephalopathy;esophageal candidiasis;mycobacterium avium complex;cryptococcosis;mycobacterium tuberculosis;progressive multifocal leukoencephalopathy;lung candidiasis;toxoplasmosis of brain;coccidiomycosis;histoplasmosis;recurrent salmonella septicemia;chronic isosporiasis;cryptosporidiosis.Incidence rate was computed as the number of events per 100,000 person-years.
  • Incidence Rate of Liver Failure [ Time Frame: Up to Week 835 ] [ Designated as safety issue: Yes ]
    Incidence rate of liver failure was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years.
  • Incidence Rate of Liver Related Death [ Time Frame: Up to Week 835 ] [ Designated as safety issue: Yes ]
    Incidence rate of liver related death was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years.
  • Incidence Rate of Rhabdomyolysis [ Time Frame: Up to Week 835 ] [ Designated as safety issue: Yes ]
    Incidence rate of Rhabdomyolysis was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years.
  • Incidence Rate of All-Cause Mortality [ Time Frame: Up to Week 835 ] [ Designated as safety issue: Yes ]
    Incidence rate of all-cause mortality was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years.
  • Incidence Rate of Viral Encephalitis [ Time Frame: Up to Week 730 ] [ Designated as safety issue: Yes ]
    Incidence rate of viral encephalitis (VE) was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years. The participants with viral encephalitis were followed-up up to 31st December 2009 (730 Weeks).
  • 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 ]
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
Not Provided
Not Provided
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
Other: non-interventional trial
No study specific intervention, non-interventional trial
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
282368
October 2013
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

HIV infection.

Exclusion Criteria:
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01339403
A4001105
No
Not Provided
Not Provided
ViiV Healthcare
ViiV Healthcare
  • Kaiser Permanente
  • Pfizer
Study Director: Pfizer CT.gov Call Center Pfizer
ViiV Healthcare
April 2015

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