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
  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 Intervention Phase
HIV
AIDS
Other: non-interventional trial
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:


Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • 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).


Enrollment: 282368
Study Start Date: February 2009
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
HIV infected
No study specific intervention, non-interventional trial
Other: non-interventional trial
No study specific intervention, non-interventional trial
HIV-uninfected
No study specific intervention, non-interventional trial
Other: non-interventional trial
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:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Results First Received: October 27, 2014
Last Updated: April 2, 2015
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 25, 2015