Prevalence and Pathogenesis of Lung Disease in a Large HIV Cohort-coordinating Center (NCT00870857) | Clinical Trial Compass
CompletedNot Applicable
Prevalence and Pathogenesis of Lung Disease in a Large HIV Cohort-coordinating Center
United States407 participantsStarted 2009-01
Plain-language summary
Despite the availability of highly active antiretroviral therapy (HAART), lung diseases remain a leading cause of morbidity and mortality in those with HIV infection. There have been no large-scale studies detailing pulmonary complications in the HAART era. Substantial gaps exist in our knowledge of the spectrum and pathogenesis of pulmonary disorders in this population, particularly in women and minorities whose numbers with HIV or AIDS have increased. The Multicenter AIDS Cohort Study (MACS) and the Women's Interagency Health Study (WIHS) are prospective, multi-center cohorts that follow approximately 5000 HIV+ subjects and HIV- controls. Although pulmonary disease has not been an area of focus, these established cohorts provide a unique opportunity to systematically study pulmonary complications of HIV infection.
Emphysema is of particular interest in the current HIV era because it is likely to increase as this population lives longer with chronic HIV. HIV-infected persons have an increased incidence of emphysema compared to those without HIV infection, and it has been hypothesized that this accelerated disease progression is the result of one or more latent infectious agents that amplify the pulmonary inflammation. Accelerated emphysema was described in HIV infection in a predominantly male population before HAART. The current prevalence and characteristics of HIV-associated emphysema, and the potential impact of gender, have not been rigorously defined.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject is Male / Female 18years of age or older.
* Subject has been previously determined to be HIV-infected or is participating in the The Multicenter AIDS Cohort Study (MACS) or the Women's Interagency Health Study (WIHS)
Exclusion Criteria:
* Subject is experiencing acute onset of shortness of breath, cough, fevers or heart conditions problems such as tachycardia, angina or arrhythmias.
* Female subject has told us she is pregnant (this might affect pulmonary function values,we will not require pregnancy testing.)
* Subject has had an MI, CVA, or cardiovascular event within the past 3 months.
* Subject has had eye or abdominal surgery within past 3 months.
* Active TB by documentation or self reported will be exclusion criteria to the study.
* Subjects will be excluded from the study if they are unable to sign consent, weigh \> 300 pounds due to technical difficulties with the CT/EBCT scanner, or have been exposed to approximately 10 rads in the previous 12 months (i.e., 2 diagnostic CT scans or 4 cardiac caths or other fluoroscopic exams).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial seems to be focused on collecting data and specimens to study the link between HIV and lung diseases like emphysema, COPD, and Pneumocystis — does this kind of observational research still have any relevance to my own care, or would it mostly benefit future patients?
2Since this trial is already completed and was based at a coordinating center in Pittsburgh, is there any published data or findings from it that my doctor could share with me to help understand my personal risk for HIV-related lung disease?
3Given that this study specifically looked at emphysema, COPD, and Pneumocystis infections in people with HIV, should I be getting screened or monitored for any of these lung conditions as part of my regular HIV care?
4Because this was an observational data-collection study rather than a treatment trial, are there any active treatment trials for HIV-related lung disease that my doctor might consider more directly useful for my situation?
5If I have any history of smoking or respiratory symptoms alongside my HIV diagnosis, does my doctor think the findings from studies like this one should change how aggressively we monitor my lung health going forward?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The overall objective of the Pitt coordinating center is to build a collaborative collection of data and specimens that will facilitate the study and understanding of HIV and pulmonary disease