Kaiser Permanente HIV Cohort Study

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	Complete list of historical versions of study NCT01339403 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other 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:
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