NCT00491335

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jun 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 18, 2007

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 26, 2007

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2010

Completed
Last Updated

July 2, 2017

Status Verified

February 16, 2010

First QC Date

June 23, 2007

Last Update Submit

June 30, 2017

Conditions

Keywords

AIDSLung CancerEmphysemaNicotineHIV InfectionSmoking

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Must be a participant in the ALIVE Study

You may not qualify if:

  • Not a participant in the ALIVE Study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Related Publications (3)

  • 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.

    PMID: 9440583BACKGROUND
  • 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.

    PMID: 11745473BACKGROUND
  • 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.

    PMID: 15220706BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeLung NeoplasmsSubstance-Related DisordersEmphysemaSmoking

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesChemically-Induced DisordersMental DisordersPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

June 23, 2007

First Posted

June 26, 2007

Study Start

June 18, 2007

Study Completion

February 16, 2010

Last Updated

July 2, 2017

Record last verified: 2010-02-16

Locations