- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01339416
HIV Cohort Study At Johns Hopkins University, University of North Carolina at Chapel Hill and Vanderbilt University
14. mars 2014 oppdatert av: ViiV Healthcare
Clinical Adverse Events In HIV-Infected Patients
Human Immunodeficiency Virus (HIV) infected patients in the HIV registries of Johns Hopkins University, University of North Carolina and Vanderbilt University will be followed in the routine clinical care to estimate the rates of prespecified clinical events in this population.
Studieoversikt
Detaljert beskrivelse
All patients identified in the HIV registries will be included without any sampling
Studietype
Observasjonsmessig
Registrering (Faktiske)
8202
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
HIV infected patients seeking treatment at Johns Hopkins University, Vanderbilt University and University of North Carolina at Chapel Hill
Beskrivelse
Inclusion Criteria:
- HIV infection.
Exclusion Criteria:
- None.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
HIV infected cohort
HIV infected patients in the HIV cohorts at the three participating hospitals
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence Rate of Malignancies
Tidsramme: Up to Week 626
|
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 from the date of HIV care initiation at that institution or January 1, 2000 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, non-Hodgkin's lymphoma and kaposis sarcoma; non-AIDS defining malignancies included but not limited to Hodgkin's disease, lung cancer, liver cancer, anal cancer, melanoma of the skin, leukemia, renal cancer, and prostate cancer.
Overall data for non-AIDS defining malignancies and individual data for AIDS-defining malignancies was reported.
Incidence rate was computed as the number of events per 100 person-years.
|
Up to Week 626
|
|
Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections
Tidsramme: Up to Week 626
|
Incidence rate of AIDS-defining opportunistic infections 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 from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date.
Opportunistic infections were those that occurred on immune-compromised participants.
AIDS-defining infections included: esophageal candidiasis; pneumocystes jiroveci; non-tuberculous mycobacterium infection; AIDS dementia complex; disseminated cryptococcosis; cytomegalovirus (all sites); wasting syndrome; toxoplasmosis; cytomegalovirus retinitis; mycobacterium tuberculosis; Progressive (Prog.)
multifocal leukoencephalopathy; histoplasmosis; cryptosporidiosis; recurrent pneumonia; herpes simplex infection; extra-pulmonary coccidioidomycosis; salmonella septicemia; isosporiasis.
|
Up to Week 626
|
|
Incidence Rate of Myocardial Infarction
Tidsramme: Up to Week 626
|
Incidence rate of myocardial infarction (MI) was calculated as the number of events divided by person-time.
Only first diagnosis of the event per participant was included.
Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date.
|
Up to Week 626
|
|
Incidence Rate of Liver Failure
Tidsramme: Up to Week 626
|
Incidence rate of liver failure was calculated as the number of events divided by person-time.
Only first diagnosis of the event per participant was included.
Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date.
|
Up to Week 626
|
|
Incidence Rate of Viral Encephalitis
Tidsramme: Up to Week 626
|
Incidence rate of viral encephalitis was calculated as the number of events divided by person-time.
Only first diagnosis of the event per participant was included.
Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date.
Viral encephalitis was defined as inflammation of the brain due to virus.
|
Up to Week 626
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence Rate of Rhabdomyolysis
Tidsramme: Up to Week 626
|
Incidence rate of rhabdomyolysis was calculated as the number of events divided by person-time.
Only first diagnosis of the event per participant was included.
Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date.
Rhabdomyolysis was a condition of muscle fibers breakdown.
|
Up to Week 626
|
|
Incidence Rate of Death
Tidsramme: Up to Week 626
|
Incidence rate of death was calculated as the number of events divided by person-time.
Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date.
All-cause mortality was used for the analyses.
|
Up to Week 626
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mars 2009
Primær fullføring (Faktiske)
1. mai 2013
Studiet fullført (Faktiske)
1. mai 2013
Datoer for studieregistrering
Først innsendt
16. mars 2011
Først innsendt som oppfylte QC-kriteriene
19. april 2011
Først lagt ut (Anslag)
20. april 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
21. april 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. mars 2014
Sist bekreftet
1. mars 2014
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- A4001106
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