Kaiser Permanente HIV Cohort Study
2 april 2015 bijgewerkt door: ViiV Healthcare
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.
Studie Overzicht
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Werkelijk)
282368
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
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
Beschrijving
Inclusion Criteria:
HIV infection.
Exclusion Criteria:
None
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
HIV infected
No study specific intervention, non-interventional trial
|
No study specific intervention, non-interventional trial
|
|
HIV-uninfected
No study specific intervention, non-interventional trial
|
No study specific intervention, non-interventional trial
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Incidence Rate of Malignancies
Tijdsspanne: 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.
|
Up to Week 835
|
|
Incidence Rate of Myocardial Infarction and Ischemia
Tijdsspanne: 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.
|
Up to Week 835
|
|
Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections
Tijdsspanne: 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.
|
Up to Week 835
|
|
Incidence Rate of Liver Failure
Tijdsspanne: 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.
|
Up to Week 835
|
|
Incidence Rate of Liver Related Death
Tijdsspanne: 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.
|
Up to Week 835
|
|
Incidence Rate of Rhabdomyolysis
Tijdsspanne: 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.
|
Up to Week 835
|
|
Incidence Rate of All-Cause Mortality
Tijdsspanne: 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.
|
Up to Week 835
|
|
Incidence Rate of Viral Encephalitis
Tijdsspanne: 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).
|
Up to Week 730
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 februari 2009
Primaire voltooiing (Werkelijk)
1 oktober 2013
Studie voltooiing (Werkelijk)
1 oktober 2013
Studieregistratiedata
Eerst ingediend
16 maart 2011
Eerst ingediend dat voldeed aan de QC-criteria
19 april 2011
Eerst geplaatst (Schatting)
20 april 2011
Updates van studierecords
Laatste update geplaatst (Schatting)
3 april 2015
Laatste update ingediend die voldeed aan QC-criteria
2 april 2015
Laatst geverifieerd
1 april 2015
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- A4001105
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