- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00823927
Alveolar Macrophage Proteomics in HIV-associated Emphysema (HIVE)
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Ohio
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Columbus, Ohio, Förenta staterna, 43026
- The Ohio State University
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Case-Control
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
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1
Alveolar macrophage proteomes from HIV-seropositive smokers with emphysema
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2
Alveolar macrophages proteomes of both HIV+ smokers without emphysema and HIV- smokers.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
examine the natural history of smoking related lung damage in patients with HIV
Tidsram: 3 years
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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.
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3 years
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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Philip T Diaz, MD, Ohio State University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2005H0197 (Annan identifierare: The Ohio State University)
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