HIV Infection and Tobacco Use Among Injection Drug Users in Baltimore, Maryland: A Pilot Study of Biomarkers

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00491335
First received: June 23, 2007
Last updated: February 17, 2010
Last verified: February 2010
  Purpose

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.

Condition
HIV Infections
AIDS
Lung Cancer
Tobacco Addiction
Drug Addiction

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: HIV Infection and Tobacco Use Among Injection Drug Users in Baltimore, MD: A Pilot Study of Biomarkers

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Study Start Date: June 2007
Estimated Study Completion Date: February 2010
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Must be a participant in the ALIVE Study

EXCLUSION CRITERIA:

Not a participant in the ALIVE Study

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00491335

Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00491335     History of Changes
Other Study ID Numbers: 999907173, 07-C-N173
Study First Received: June 23, 2007
Last Updated: February 17, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
AIDS
Lung Cancer
Emphysema
Nicotine
HIV Infection
Smoking

Additional relevant MeSH terms:
Infection
Communicable Diseases
Lung Neoplasms
HIV Infections
Acquired Immunodeficiency Syndrome
Behavior, Addictive
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Compulsive Behavior
Impulsive Behavior

ClinicalTrials.gov processed this record on October 19, 2014