- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00491335
HIV Infection and Tobacco Use Among Injection Drug Users in Baltimore, Maryland: A Pilot Study of Biomarkers
HIV Infection and Tobacco Use Among Injection Drug Users in Baltimore, MD: A Pilot Study of Biomarkers
Background:
The incidence of lung cancer is quite high among people with the human immunodeficiency (HIV) virus. Frequent smoking may explain that cancer increase, given that 50% to 70% of HIV-infected people are current smokers.
Recent research suggests that other factors may be involved as well. Smoking habits, such as smoking earlier in life or smoking more cigarettes a day than others do, may have a role. Also, HIV-infected smokers seem to have a greater risk of chronic obstructive pulmonary disease (COPD). The association of HIV and COPD is important, because COPD itself is linked to an increased risk of lung cancer.
About 1,600 subjects from the study known as ALIVE (AIDS Linked to the Intra-Venous Experience), which began in 1988 in Baltimore, Maryland, will be given a detailed questionnaire on smoking behaviors and lung cancer risk factors. They will also have spirometry testing, to evaluate lung function.
Objectives:
To better characterize smoking habits and compare tobacco use among HIV-infected and uninfected drug users.
To compare serum cotinine levels and spirometry results, as a marker of tobacco use and a marker of damage to lung function, respectively.
Eligibility:
Patients 18 years of age and older who are in the ALIVE cohort.
Design:
Patients undergo the following procedures:
- Completing a questionnaire on smoking history. Questions include age when smoking began, periods of quitting smoking, average number of cigarettes per day for specific periods, amount of each cigarette smoked, depth of inhalation, type of cigarette, nicotine dependence, use of other smoked [Note: I would not mention that these drugs are illegal] drugs, exposure to environmental tobacco smoke, past medical history, and recent respiratory symptoms.
- Spirometry testing. Patients are asked to breathe as deeply as possible and then rapidly exhale into a tube. The forced expiration volume in 1 second reflects the average flow rate during the first second, and it can be used to determine the degree of pulmonary obstruction.
- Blood samples. Tests measure levels of cotinine, a chemical made by the body from nicotine. African American males, who constitute the majority of the ALIVE cohort, participate in this test. Results would show how much tobacco smoke has recently entered the body. For this test, researchers plan to evaluate 240 current tobacco smokers and 100 participants who report no recent cigarette use.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Studientyp
Kontakte und Standorte
Studienorte
-
-
Maryland
-
Baltimore, Maryland, Vereinigte Staaten, 21205
- Johns Hopkins University
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
- INCLUSION CRITERIA:
Must be a participant in the ALIVE Study
EXCLUSION CRITERIA:
Not a participant in the ALIVE Study
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Parker MS, Leveno DM, Campbell TJ, Worrell JA, Carozza SE. AIDS-related bronchogenic carcinoma: fact or fiction? Chest. 1998 Jan;113(1):154-61. doi: 10.1378/chest.113.1.154.
- Phelps RM, Smith DK, Heilig CM, Gardner LI, Carpenter CC, Klein RS, Jamieson DJ, Vlahov D, Schuman P, Holmberg SD; HER Study Group. Cancer incidence in women with or at risk for HIV. Int J Cancer. 2001 Dec 1;94(5):753-7. doi: 10.1002/ijc.1528.
- Hessol NA, Seaberg EC, Preston-Martin S, Massad LS, Sacks HS, Silver S, Melnick S, Abulafia O, Levine AM; WIHS Collaborative Study Group. Cancer risk among participants in the women's interagency HIV study. J Acquir Immune Defic Syndr. 2004 Aug 1;36(4):978-85. doi: 10.1097/00126334-200408010-00013.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Psychische Störungen
- Chemisch induzierte Störungen
- Pathologische Prozesse
- RNA-Virusinfektionen
- Viruserkrankungen
- Durch Blut übertragene Infektionen
- Sexuell übertragbare Krankheiten, viral
- Sexuell übertragbare Krankheiten
- Lentivirus-Infektionen
- Retroviridae-Infektionen
- Immunologische Mangelsyndrome
- Erkrankungen des Immunsystems
- Krankheitsattribute
- Langsame Viruserkrankungen
- Zwangsverhalten
- Impulsives Verhalten
- Substanzbezogene Störungen
- HIV-Infektionen
- Infektionen
- Übertragbare Krankheiten
- Erworbenes Immunschwächesyndrom
- Verhalten, Sucht
Andere Studien-ID-Nummern
- 999907173
- 07-C-N173
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur HIV-Infektionen
-
Duke UniversityAbgeschlossenCentral Line-associated Bloodstream Infection (CLABSI)Vereinigte Staaten
-
Catholic University of the Sacred HeartAbgeschlossenCentral Line-associated Bloodstream Infection (CLABSI)
-
Abbott Medical DevicesThoratec CorporationAbgeschlossenDriveline Heart-assisted Device Related InfectionVereinigte Staaten
-
Princess Maxima Center for Pediatric OncologyUMC Utrecht; Dutch Cancer SocietyRekrutierungCentral Line-associated Bloodstream Infection (CLABSI)Niederlande
-
University of MalayaTeleflexRekrutierungCLABSI – Central Line Associated Bloodstream InfectionMalaysia
-
National Taiwan University Hospital Hsin-Chu BranchAbgeschlossenCentral Line-associated Bloodstream Infection (CLABSI)
-
Johns Hopkins UniversityAbgeschlossenCLABSI – Central Line Associated Bloodstream InfectionVereinigte Staaten
-
National Taiwan University HospitalAbgeschlossenCentral Line-associated Bloodstream Infection (CLABSI)Taiwan
-
University of ZurichNoch keine RekrutierungCentral Line-associated Bloodstream Infection (CLABSI) | Katheterbedingte Blutstrominfektion
-
Princess Anna Mazowiecka Hospital, Warsaw, PolandNutricia FoundationAktiv, nicht rekrutierendWachstumsfehler | CLABSI – Central Line Associated Bloodstream InfectionPolen