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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00491335
• Other study ID #: 999907173
• Secondary ID: 07-C-N173
• Status: Completed
• Phase: N/A
• First received: June 23, 2007
• Last updated: June 30, 2017
• Start date: June 18, 2007
• Est. completion date: February 16, 2010

Study information

• Verified date: February 16, 2010
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: February 16, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

• INCLUSION CRITERIA:

Must be a participant in the ALIVE Study

EXCLUSION CRITERIA:

Not a participant in the ALIVE Study

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• AIDS
• Behavior, Addictive
• Communicable Diseases
• Drug Addiction
• HIV Infections
• Infection
• Lung Cancer
• Substance-Related Disorders
• Tobacco Addiction

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

Parker MS, Leveno DM, Campbell TJ, Worrell JA, Carozza SE. AIDS-related bronchogenic carcinoma: fact or fiction? Chest. 1998 Jan;113(1):154-61. — View Citation

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. — View Citation