HIVHIVENCT00823927
Alveolar Macrophage Proteomics in HIV-associated Emphysema
An observational study of HIV and Emphysema, run by Philip Diaz at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Emphysema, HIV Infections
- How many people
- 365 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2006to 23 Jun 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: community sample
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- HIV, Emphysema, HIV Infections
- Keywords
- lung damage, cigarette smoking, HIV-seropositive, emphysema
- Medical subject headings
- Emphysema, HIV Infections, Cigarette Smoking, HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Alveolar macrophage proteomes from HIV-seropositive smokers with emphysema | |
| 2 | Alveolar macrophages proteomes of both HIV+ smokers without emphysema and HIV- smokers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
examine the natural history of smoking related lung damage in patients with HIV
HIV-Seropositive individuals are at increased risk of developing pulmonary emphysema (1,2). With improved therapy for HIV, and increased life expectancy in this population with a high smoking prevalence, chronic obstructive pulmonary disease (COPD) may assume an increasingly important role with respect to health related quality of life and medical complications. This research will provide a unique opportunity to examine the natural history of smoking related lung damage in patients with HIV infection. In addition, this research will involve sampling of lung cells to determine if there are unique proteins present that may be related to the increased risk of emphysema in this population. This may shed important insight into how the lung responds to injury and how it repairs itself. If critical proteins can be identified, treatment strategies may eventually be developed to either decrease proteins causing injury or increase protective proteins.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2009 (estimated)
- Study start21 Apr 2006
- Primary completion23 Jun 2008
- Study completion23 Jun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philip Diaz
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor-investigator, Philip Diaz, Ohio State University
- Investigators
- Philip T Diaz, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00823927
- Sponsor's protocol ID
- 2005H0197
- Other IDs
- 2005H0197
- Acronym
- HIVE
- Status last verified
- Oct 2021
- First submitted
- 15 Jan 2009
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alveolar Macrophage Proteomics in HIV-associated Emphysema
- ClinicalTrials.gov ID
- NCT00823927
- Acronym / sponsor ID
- HIVE / 2005H0197
- Conditions
- HIV, Emphysema, HIV Infections
- Keywords
- lung damage, cigarette smoking, HIV-seropositive, emphysema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- Philip DiazUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 21 Apr 2006 (actual)
- Primary completion
- 23 Jun 2008 (actual)
- Study completion
- 23 Jun 2008 (actual)
- First posted
- 16 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Alveolar macrophage proteomes from HIV-seropositive smokers with emphysema |
| 2 | – | –Alveolar macrophages proteomes of both HIV+ smokers without emphysema and HIV- smokers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- community sample
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
examine the natural history of smoking related lung damage in patients with HIV
Time frame: 3 years
HIV-Seropositive individuals are at increased risk of developing pulmonary emphysema (1,2). With improved therapy for HIV, and increased life expectancy in this population with a high smoking prevalence, chronic obstructive pulmonary disease (COPD) may assume an increasingly important role with respect to health related quality of life and medical complications. This research will provide a unique opportunity to examine the natural history of smoking related lung damage in patients with HIV infection. In addition, this research will involve sampling of lung cells to determine if there are unique proteins present that may be related to the increased risk of emphysema in this population. This may shed important insight into how the lung responds to injury and how it repairs itself. If critical proteins can be identified, treatment strategies may eventually be developed to either decrease proteins causing injury or increase protective proteins.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip T Diaz, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Emphysema, run by Philip Diaz at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
examine the natural history of smoking related lung damage in patients with HIV (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.