Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01339403
Previous Study | Return to List | Next Study

Kaiser Permanente HIV Cohort Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01339403
Recruitment Status : Completed
First Posted : April 20, 2011
Results First Posted : April 3, 2015
Last Update Posted : April 3, 2015
Sponsor:
Collaborators:
Kaiser Permanente
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare

Tracking Information
First Submitted Date March 16, 2011
First Posted Date April 20, 2011
Results First Submitted Date October 27, 2014
Results First Posted Date April 3, 2015
Last Update Posted Date April 3, 2015
Study Start Date February 2009
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 2, 2015)
  • Incidence Rate of Malignancies [ Time Frame: Up to Week 835 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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).
Original Primary Outcome Measures
 (submitted: April 19, 2011)
  • Incidence rate of Malignancies [ Time Frame: Mean follow up of 4 years ]
  • Incidence rate of Myocardial infarction [ Time Frame: Mean follow up of 4 years ]
  • Incidence rate of Myocardial ischemia [ Time Frame: Mean follow up of 4 years ]
  • Incidence rate of AIDS defining opportunistic infections [ Time Frame: Mean follow up of 4 years ]
  • Incidence Rate of Liver Failure [ Time Frame: Mean follow up of 4 years ]
  • Incidence Rate of Liver Related Death [ Time Frame: Mean follow up of 4 years ]
  • Incidence Rate of Rhabdomyolysis [ Time Frame: Mean follow up of 4 years ]
  • Incidence Rate of All-Cause Mortality [ Time Frame: Mean follow up of 4 years ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center Pfizer
PRS Account ViiV Healthcare
Verification Date April 2015