Trial record 2 of 28 for:    " December 24, 2008":" January 23, 2009"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Alveolar Macrophage Proteomics in HIV-associated Emphysema (HIVE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Philip Diaz, The Ohio State University
ClinicalTrials.gov Identifier:
NCT00823927
First received: January 15, 2009
Last updated: October 24, 2012
Last verified: October 2012
  Purpose

This study is being done to examine lung function changes in individuals with HIV infection and to understand why individuals with HIV have increased risk of lung damage from cigarette smoking.


Condition
HIV
Emphysema
HIV Infections

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Alveolar Macrophage Proteomics in HIV-associated Emphysema

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Biospecimen Retention:   Samples With DNA

blood lung fluid (optional)


Enrollment: 365
Study Start Date: March 2006
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
HIV smokers with emphysema
2
HIV smokers without emphysema

Detailed Description:

To delineate the natural history of HIV associated emphysema in the HAART era. To compare the alveolar macrophage proteomes from HIV-seropositive smokers with emphysema to the alveolar macrophages proteomes of both HIV+ smokers without emphysema and HIV- smokers.

To establish whether coinfection with HIV and Hepatitis C results in accelerated lung disease manifested by decrements in forced expiratory volume and carbon monoxide diffusing capacity.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

community sample

Criteria

Inclusion Criteria:

  • Clinically stable HIV-seropositive (and HIV-seronegative) individuals
  • Ages 18 years and older
  • Female subjects on no oral contraception with a negative pregnancy test
  • Subjects capable of giving written consent

Exclusion Criteria:

  • Known medical illness that would preclude bronchoscopy/BAL (e.g. unstable angina, new cardiac arrhythmia). This only pertains to subjects involved in the bronchoscopy phase of the study.
  • Pregnant females
  • Prisoners
  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: NCT00823927

Locations
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43026
Sponsors and Collaborators
Philip Diaz
Investigators
Principal Investigator: Philip T Diaz, MD Ohio State University
  More Information

No publications provided

Responsible Party: Philip Diaz, MD, The Ohio State University
ClinicalTrials.gov Identifier: NCT00823927     History of Changes
Other Study ID Numbers: 2005H0197
Study First Received: January 15, 2009
Last Updated: October 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
lung damage
cigarette smoking
HIV-seropositive
emphysema

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Emphysema
Pulmonary Emphysema
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
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 23, 2014