Kaiser Permanente HIV Cohort Study
2015. április 2. frissítette: 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.
A tanulmány áttekintése
Részletes leírás
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.
Tanulmány típusa
Megfigyelő
Beiratkozás (Tényleges)
282368
Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
18 év és régebbi (Felnőtt, Idősebb felnőtt)
Egészséges önkénteseket fogad
Nem
Tanulmányozható nemek
Összes
Mintavételi módszer
Nem valószínűségi minta
Tanulmányi populáció
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
Leírás
Inclusion Criteria:
HIV infection.
Exclusion Criteria:
None
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
Kohorszok és beavatkozások
Csoport / Kohorsz |
Beavatkozás / kezelés |
|---|---|
|
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
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Incidence Rate of Malignancies
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
|
Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Publikációk és hasznos linkek
A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete
2009. február 1.
Elsődleges befejezés (Tényleges)
2013. október 1.
A tanulmány befejezése (Tényleges)
2013. október 1.
Tanulmányi regisztráció dátumai
Először benyújtva
2011. március 16.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2011. április 19.
Első közzététel (Becslés)
2011. április 20.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Becslés)
2015. április 3.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2015. április 2.
Utolsó ellenőrzés
2015. április 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Egyéb vizsgálati azonosító számok
- A4001105
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .