Kaiser Permanente HIV Cohort Study

HIV Clinical Trial

Official title:

Hiv Infection, Antiretroviral Therapy Use And Other Predictors Of Selected Clinical Events In Kaiser Permanente

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01339403
• Other study ID #: A4001105
• Status: Completed
• Phase: Phase 4
• First received: March 16, 2011
• Last updated: April 2, 2015
• Start date: February 2009
• Est. completion date: October 2013

Study information

• Verified date: April 2015
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 282368
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

HIV infection.

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• AIDS
• HIV

Intervention

Other:
• non-interventional trial
No study specific intervention, non-interventional trial
• non-interventional trial
No study specific intervention, non-interventional trial

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
ViiV Healthcare	Kaiser Permanente, Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence Rate of Malignancies	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.	Up to Week 835	Yes
Primary	Incidence Rate of Myocardial Infarction and Ischemia	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.	Up to Week 835	Yes
Primary	Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections	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.	Up to Week 835	Yes
Primary	Incidence Rate of Liver Failure	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.	Up to Week 835	Yes
Primary	Incidence Rate of Liver Related Death	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.	Up to Week 835	Yes
Primary	Incidence Rate of Rhabdomyolysis	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.	Up to Week 835	Yes
Primary	Incidence Rate of All-Cause Mortality	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.	Up to Week 835	Yes
Primary	Incidence Rate of Viral Encephalitis	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).	Up to Week 730	Yes

External Links

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