- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00823927
Alveolar Macrophage Proteomics in HIV-associated Emphysema (HIVE)
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
To delineate the natural history of HIV associated emphysema in the HAART era. To compare the alveolar macrophage proteomes from HIV-seropositive smokers with emphysema to the alveolar macrophages proteomes of both HIV+ smokers without emphysema and HIV- smokers.
To establish whether coinfection with HIV and Hepatitis C results in accelerated lung disease manifested by decrements in forced expiratory volume and carbon monoxide diffusing capacity.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Ohio
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Columbus, Ohio, Forenede Stater, 43026
- The Ohio State University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Clinically stable HIV-seropositive (and HIV-seronegative) individuals
- Ages 18 years and older
- Female subjects on no oral contraception with a negative pregnancy test
- Subjects capable of giving written consent
Exclusion Criteria:
- Known medical illness that would preclude bronchoscopy/BAL (e.g. unstable angina, new cardiac arrhythmia). This only pertains to subjects involved in the bronchoscopy phase of the study.
- Pregnant females
- Prisoners
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Case-Control
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
1
Alveolar macrophage proteomes from HIV-seropositive smokers with emphysema
|
|
2
Alveolar macrophages proteomes of both HIV+ smokers without emphysema and HIV- smokers.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
examine the natural history of smoking related lung damage in patients with HIV
Tidsramme: 3 years
|
HIV-Seropositive individuals are at increased risk of developing pulmonary emphysema (1,2).
With improved therapy for HIV, and increased life expectancy in this population with a high smoking prevalence, chronic obstructive pulmonary disease (COPD) may assume an increasingly important role with respect to health related quality of life and medical complications.
This research will provide a unique opportunity to examine the natural history of smoking related lung damage in patients with HIV infection.
In addition, this research will involve sampling of lung cells to determine if there are unique proteins present that may be related to the increased risk of emphysema in this population.
This may shed important insight into how the lung responds to injury and how it repairs itself.
If critical proteins can be identified, treatment strategies may eventually be developed to either decrease proteins causing injury or increase protective proteins.
|
3 years
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Philip T Diaz, MD, Ohio State University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2005H0197 (Anden identifikator: The Ohio State University)
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