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View Clinical Trial (Medical Research Study)
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HIV Infection and Tobacco Use Among Injection Drug Users in Baltimore, Maryland: A Pilot Study of Biomarkers - NCT00491335-21205 (Clinical Trial 174585)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy174585.aspx
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| City: |
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Baltimore |
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State:
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MD |
| Zip Code: |
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21205 |
| Conditions: |
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HIV Infections - AIDS - Lung Cancer - Tobacco Addiction - Drug Addiction |
| Purpose: |
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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.
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| Study summary: |
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Lung cancer incidence is substantially elevated among people infected with human
immunodeficiency virus (HIV). Although frequent smoking may partly explain this increase,
recent work suggests other factors may also be involved. To better characterize smoking
habits and lung cancer risk in HIV-infected people, the investigators propose a
cross-sectional pilot study of HIV-infected and uninfected injection drug users in the ALIVE
cohort in Baltimore, Maryland. A detailed questionnaire on smoking behaviors and other lung
cancer risk factors will be administered to all ~ 1600 cohort subjects. In addition, the
investigators will measure serum cotinine (a marker of recent smoking intensity) for a
sample of 340 African American males from the cohort, stratified on the amount of cigarette
use, HIV status, and CD4 count. Spirometry will be performed on the entire group of 1600
subjects, to assess for chronic obstructive pulmonary disease. Differences between
HIV-infected and uninfected subjects in smoking habits, exposure to tobacco, or lung damage
will identify areas for future investigation. |
| Criteria: |
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- INCLUSION CRITERIA:
Must be a participant in the ALIVE Study
EXCLUSION CRITERIA:
Not a participant in the ALIVE Study |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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