- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01339416
HIV Cohort Study At Johns Hopkins University, University of North Carolina at Chapel Hill and Vanderbilt University
14 mars 2014 uppdaterad 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.
Studieöversikt
Detaljerad beskrivning
All patients identified in the HIV registries will be included without any sampling
Studietyp
Observationell
Inskrivning (Faktisk)
8202
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
HIV infected patients seeking treatment at Johns Hopkins University, Vanderbilt University and University of North Carolina at Chapel Hill
Beskrivning
Inclusion Criteria:
- HIV infection.
Exclusion Criteria:
- None.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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HIV infected cohort
HIV infected patients in the HIV cohorts at the three participating hospitals
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Incidence Rate of Malignancies
Tidsram: 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
Tidsram: 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
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Incidence Rate of Myocardial Infarction
Tidsram: 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.
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Up to Week 626
|
Incidence Rate of Liver Failure
Tidsram: 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
Tidsram: 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.
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Up to Week 626
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Incidence Rate of Rhabdomyolysis
Tidsram: 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.
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Up to Week 626
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Incidence Rate of Death
Tidsram: 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.
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Up to Week 626
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 mars 2009
Primärt slutförande (Faktisk)
1 maj 2013
Avslutad studie (Faktisk)
1 maj 2013
Studieregistreringsdatum
Först inskickad
16 mars 2011
Först inskickad som uppfyllde QC-kriterierna
19 april 2011
Första postat (Uppskatta)
20 april 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
21 april 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 mars 2014
Senast verifierad
1 mars 2014
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- A4001106
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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