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| Lung HIV Study Overview |
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Longitudinal Studies of HIV-Associated Lung Infections and Complications (RFA: HL07-008) Overview of Projects by Clinical Center
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| Clinical Center 1 |
Johns Hopkins University - Medicine |
| Study (PI) |
Longitudinal Evaluation of Lung Health in a Soweto cohort of HIV-infected adults (PI, Richard Chaisson, Co-PI, Neil Martinson) |
| Goal/Intervention |
- Establish a database and tissue repository from a clinical cohort of HIV-infected South Africans.
- Assess the epidemiology, natural history and clinical course of AIDS-associated lung diseases longitudinally.
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| Enrollment Sites |
South Africa |
| Affiliated Cohort Study |
HIV Wellness Cohort, Soweto; Novel TB preventive Therapy Study Cohort (1, 2) |
| Patient Population |
1000 HIV+ adults from Soweto, South Africa.
500 from previous RCT of TB preventive therapy regimens,
500 from HIV Wellness Clinic.
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| Clinical Center 2 |
Johns Hopkins University Bloomberg School of Public Health |
| Study (PI) |
Study of HIV Infection in the Etiology of Lung Disease (SHIELD) (PI, Gregory Kirk) |
| Goal/Intervention |
- Investigate the prevalence or incidence, and risk factors for non-infectious lung disease, including COPD, lung cancer and pulmonary arterial hypertension.
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| Enrollment Sites |
USA |
| Affiliated Cohort Study |
Three affiliated HIV cohort studies in Baltimore: AIDS Linked to the IntraVenous Experience (ALIVE), Johns Hopkins HIV Clinical Cohort (JHHCC), Study to Help the AIDS Research Effort (SHARE)(3-5)
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| Patient Population |
Approximately 3500 HIV+ outpatients enrolled in parent cohort studies; 450 of these are enrolled in focused COPD and 750 in PAH studies.
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| Clinical Center 3 |
New York University School of Medicine |
| Study (PI) |
Longitudinal Studies of HIV-Associated Bacterial Pneumonia (PI, William Rom) |
| Goal/Intervention |
- Follow 400 HIV+ subjects for bacterial pneumonia.
- Evaluate BAL and peripheral blood specimens for differences in cytokines, cell surface molecules, and HIV replication and mutations.
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| Enrollment Sites |
USA and South Africa |
| Affiliated Cohort Study |
N/A |
| Patient Population |
400 HIV+ subjects enrolled. Bacterial Pneumonia diagnosed in ~36 patients at each site lavaged for mechanistic studies focused on HIV and bacterial pneumonia. Two control HIV+ patients lavaged at the same time for studies on lung HIV, neutrophils and alveolar macrophages.
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| Clinical Center 4 |
Ohio State University |
| Study (PI) |
Smoking cessation and the natural history of HIV-associated emphysema (PI, Philip Diaz) |
| Goal/Intervention |
- Examine the effects of smoking cessation on respiratory symptoms, pulmonary function and alveolar macrophage biology in a cohort of HIV+ smokers.
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| Enrollment Sites |
USA |
| Affiliated Cohort Study |
N/A |
| Patient Population |
365 HIV+ current smokers |
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| Clinical Center 5 |
University of California San Francisco |
| Study (PI) |
International HIV-associated Opportunistic Pneumonias (IHOP) Study (PI, Laurence Huang) |
| Goal/Intervention |
- Determine the frequency and mortality of HIV-associated opportunistic pneumonias.
- Evaluate the sensitivity and specificity of molecular tools for PCP and pulmonary TB diagnosis.
- Determine the frequency of Pneumocystis dihydropteroate synthase (DHPS) gene mutations and study putative mechanisms for trimethoprim-sulfamethoxazole drug resistance.
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| Enrollment Sites |
USA, Uganda |
| Affiliated Cohort Study |
N/A |
| Patient Population |
2400-3000 HIV+ inpatients with suspected pneumonia |
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| Clinical Center 6 |
University of Colorado Health Science Center |
| Study (PI) |
Longitudinal studies of HIV-1 Nef in Pulmonary Hypertension (PI, Sonia Flores) |
| Goal/Intervention |
- Determine if particular HIV Nef signature sequences are associated with and predict HIV-related pulmonary hypertension.
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| Enrollment Sites |
France, USA |
| Affiliated Cohort Study |
N/A |
| Patient Population |
80 HIV+ patients with PAH and 60 HIV+ patients without PAH |
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| Clinical Center 7 |
University of Pittsburgh |
| Study (PI) |
Prevalence & Pathogenesis of Pulmonary Disease in a Large Multicenter HIV Cohort (PI, Alison Morris) |
| Goal/Intervention |
- Describe epidemiology and risk factors for pulmonary disease in the current era.
- Determine if COPD is more prevalent and progresses more quickly in those with HIV infection compared to controls.
- Evaluate the role of infections in HIV-associated COPD.
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| Enrollment Sites |
USA |
| Affiliated Cohort Study |
Multicenter AIDS Cohort Study (MACS) and Womens Interagency HIV Study (WIHS) cohorts(5, 6) |
| Patient Population |
4000 HIV+ and HIV- outpatients enrolled in MACS and WIHS, with 600 of these enrolled in emphysema studies. |
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| Clinical Center 8 |
University of Washington |
| Study (PI) |
Investigations in HIV Associated Lung Events (INHALE) and Examinations of HIV Associated Lung Emphysema (EXHALE) Studies (PI, Kristina Crothers)
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| Goal/Intervention |
- Understand the epidemiology of lung diseases in HIV, and smoking as a risk factor.
- Compare clinical and pathophysiologic differences in COPD and decline in pulmonary function between HIV+ and HIV- patients.
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| Enrollment Sites |
USA |
| Affiliated Cohort Study |
Veterans Aging Cohort Study (VACS)(7) |
| Patient Population |
Approximately 3500 HIV+ and 3500 HIV- veterans enrolled in VACS for INHALE; with 180 HIV+ and 180 HIV-participants with or at risk for COPD prospectively enrolled in EXHALE; those with lung diseases other than COPD are excluded from EXHALE.
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| Major domains included in baseline patient surveys in the Lung HIV Common Database |
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| Domain |
Source (References) |
| Demographics |
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| Age, gender, race/ethnicity, education, employment, socioeconomic status |
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| HIV history and Antiretroviral medications |
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| HIV risk factor(s) |
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| Antiretroviral therapy use |
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| Respiratory symptoms |
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| Usual cough, phlegm, wheeze |
American Thoracic Society Division of Lung Diseases (ATS-DLD) survey(8) |
| Dyspnea |
Medical Research Council (MRC) dyspnea scale(9) |
| History of lung diseases |
ATS-DLD survey(8) and National Health Interview Survey (NHIS)(10) |
Opportunistic pneumonia (e.g., BP, PCP, TB) |
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| Non-infections complications (e.g., COPD, asthma, PAH) |
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| Smoking, alcohol and substance use |
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| Smoking status and pack years |
(NHIS)(10) |
| Nicotine dependence |
Fagerstrom Test of Nicotine Dependence(11) |
| Cessation attempts |
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| Cigar and pipe smoking |
NHIS(10) |
| Hazardous alcohol use |
Alcohol Use Disorders Identification Test (AUDIT-C)(12, 13) |
| Illicit drug use |
AIDS-Link to the IntraVenous Experience (ALIVE)(3) |
| Occupational and environmental exposures |
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| Vapors, gases, dusts, fumes |
Occupational burden of COPD(14) |
| Indoor mold |
ATS-DLD(8) |
| Second-hand smoke |
ATS-DLD(8) |
| Family history |
ATS-DLD(8) |
| Health-related quality of life |
Short-form (SF)-8(15) |
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| Abbreviations: |
| BAL bronchoalveolar lavage |
| BP bacterial pneumonia |
| COPD Chronic obstructive pulmonary disease |
| HIV+ - HIV-infected |
| PAH pulmonary arterial hypertension |
| PCP Pneumocystis pneumonia |
| RCT Randomized controlled trial |
| TB tuberculosis |
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Common Data Elements collected at Clinical Centers that comprise the Lung HIV Common Database
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Site 1 |
Site 2 |
Site 3 |
Site 4 |
Site 5 |
Site 6 |
Site 7 |
Site 8 |
| Demographics |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
| Surveys (see Table 2) |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
| Pulmonary diagnoses |
Yes |
Yes |
Yes |
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Yes |
Yes |
Yes |
Yes |
| Laboratory values |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
| Pulmonary function testing |
Yes |
Yes |
Yes |
Yes |
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Yes |
Yes |
| Chest CT scans |
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Yes |
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Yes |
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Yes |
Yes |
| Peripheral blood collection |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
| Bronchoscopy |
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Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
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| References |
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- Golub JE, Pronyk P, Mohapi L, Thsabangu N, Moshabela M, Struthers H, Gray GE, McIntyre JA, Chaisson RE, Martinson NA. Isoniazid preventive therapy, haart and tuberculosis risk in hiv-infected adults in south africa: A prospective cohort. AIDS 2009;23:631-636.
- Hanrahan CF, Golub JE, Mohapi L, Tshabangu N, Modisenyane T, Chaisson RE, Gray GE, McIntyre JA, Martinson NA. Bmi and risk of tuberculosis and death: A prospective cohort of hiv-infected adults from south africa. AIDS 2010.
- Vlahov D, Anthony JC, Munoz A, Margolick J, Nelson KE, Celentano DD, Solomon L, Polk BF. The alive study, a longitudinal study of hiv-1 infection in intravenous drug users: Description of methods and characteristics of participants. NIDA Res Monogr 1991;109:75-100.
- Moore RD. Understanding the clinical and economic outcomes of hiv therapy: The johns hopkins HIV clinical practice cohort. J Acquir Immune Defic Syndr Hum Retrovirol 1998;17 Suppl 1:S38-41.
- Kaslow RA, Ostrow DG, Detels R, Phair JP, Polk BF, Rinaldo CR, Jr. The multicenter aids cohort study: Rationale, organization, and selected characteristics of the participants. Am J Epidemiol 1987;126:310-318.
- Barkan SE, Melnick SL, Preston-Martin S, Weber K, Kalish LA, Miotti P, Young M, Greenblatt R, Sacks H, Feldman J. The women's interagency hiv study. Wihs collaborative study group. Epidemiology 1998;9:117-125.
- Justice AC, Dombrowski E, Conigliaro J, Fultz SL, Gibson D, Madenwald T, Goulet J, Simberkoff M, Butt AA, Rimland D, Rodriguez-Barradas MC, Gibert CL, Oursler KA, Brown S, Leaf DA, Goetz MB, Bryant K. Veterans aging cohort study (vacs): Overview and description. Med Care 2006;44:S13-24.
- Ferris BG. Epidemiology standardization project (american thoracic society). Am Rev Respir Dis 1978;118:1-120.
- Bestall JC, Paul EA, Garrod R, Garnham R, Jones PW, Wedzicha JA. Usefulness of the medical research council (mrc) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease. Thorax 1999;54:581-586.
- 2004 national health interview survey (nhis). Division of Health Interview Statistics, National Center for Health Statistics, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services; 2005.
- Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The fagerstrom test for nicotine dependence: A revision of the fagerstrom tolerance questionnaire. Br J Addict 1991;86:1119-1127.
- Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M. Development of the alcohol use disorders identification test (audit): Who collaborative project on early detection of persons with harmful alcohol consumption--ii. Addiction 1993;88:791-804.
- Shah M, Variava E, Holmes CB, Coppin A, Golub JE, McCallum J, Wong M, Luke B, Martin DJ, Chaisson RE, Dorman SE, Martinson NA. Diagnostic accuracy of a urine lipoarabinomannan test for tuberculosis in hospitalized patients in a high hiv prevalence setting. J Acquir Immune Defic Syndr 2009;52:145-151.
- Trupin L, Earnest G, San Pedro M, Balmes JR, Eisner MD, Yelin E, Katz PP, Blanc PD. The occupational burden of chronic obstructive pulmonary disease. Eur Respir J 2003;22:462-469.
- Lefante JJ, Jr., Harmon GN, Ashby KM, Barnard D, Webber LS. Use of the sf-8 to assess health-related quality of life for a chronically ill, low-income population participating in the central louisiana medication access program (cmap). Qual Life Res 2005;14:665-673.
- Global initiative for chronic obstructive lung disease strategy for the diagnosis, management and prevention of chronic obstructive pulmonary disease: An asia-pacific perspective. Respirology 2005;10:9-17.
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