HIVNCT02058719
Immunosuppressive Effects of Smoking and HIV-1 on the Development of Lung Disease
An observational study of HIV and Smoking, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study plans to learn more about pulmonary complications of human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS). Even though antiretroviral therapy (ART) has dramatically decreased the number of opportunistic infections and deaths in HIV infected patients, pulmonary complications (including… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Dec 2019
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: HIV positive (smokers and non-smokers) and negative subjects (smokers and non-smokers) will be recruited. HIV positive (with and without COPD) and HIV negative with COPD will also be recruited. All subjects will be between ages 18 and 70.
Who may be able to join
- Subjects with chronic HIV-1 infection (Cohorts A1 and A2)
- ART naïve or off all ART for >6 months (Cohorts A1 and A2)
- HIV-1 RNA level >1,000 copies/ml (Cohorts A1 and A2)
- HIV-1 seronegative with no high-risk exposure in the past 30 days (Cohorts A3 and A4)
- 18 years and older (All Cohort A)
- Active cigarette smoker (Cohorts A1 and A3)
Show all 11Show fewer
- Age from 30 to 70 years
- Subjects with chronic HIV-1 infection (Cohorts B1 and B2)
- Subjects on stable 3-drug ART regimen with plasma HIV-1 RNA <50 copies/mL for past 6 months (Cohorts B1 and B2)
- HIV-1 seronegative with no high-risk exposure in the past 30 days (Cohort B3) COPD: forced expiratory volume at one second (FEV1)/forced vital capacity (FVC) <70% and forced expiratory volume (FEV), 45-100% of predicted (Cohort B1 and B3)
- Non-COPD: FEV/FVC >70% and an FEV, >80% of predicted (Cohort B2)
Who cannot join
- Pregnancy
- Weight less than 110 pounds (for venipuncture)
- Patient inability to participate in the study and undergo venipuncture and bronchoscopy procedures
- Use of systemic or inhaled corticosteroids in the past 3 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
Official title: Immunosuppressive Effects of Smoking and HIV-1 on the Development of Lung Disease.
This study plans to learn more about pulmonary complications of human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS). Even though antiretroviral therapy (ART) has dramatically decreased the number of opportunistic infections and deaths in HIV infected patients, pulmonary complications (including chronic obstructive pulmonary disease (COPD) development and pneumonias resulting in decreased lung function) of HIV/AIDS continue to be a major cause of morbidity and mortality in this population. The mechanisms underlying the increased risk of COPD and decreased lung function in HIV infected individuals is not well understand and needs to be studied.
The investigators hypothesize that the immunoregulatory consequences and immunosuppressive lung milieu secondary to HIV and cigarette smoke combine to increase the risk of lung infection and injury in HIV infected smokers, hastening the development of COPD. The mechanisms will be directly tested using blood and bronchial alveolar lavage (BAL) cells from smokers and nonsmokers with and without HIV infection.
Read the detailed description
The first component of this study will be a longitudinal, prospective, 24 weeks study of the effects of HIV-1 infection on innate and acquired immunity in the lung (Cohort A). The second component of this study will be a cross-sectional, case-control study of lung function and immune dysregulation of HIV-1 infected persons on long-term ART (Cohort B).
Cohort A will consist of 120 subjects, stratified by HIV-1 and smoking status
Cohort B will consist of 90 subjects stratified by chronic obstructive pulmonary disease (COPD) and HIV-1 infection.
- Medical subject headings
- Smoking, Pulmonary Disease, Chronic Obstructive
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 |
|---|---|---|
| Cohort A1 | HIV positive smokers | |
| Cohort A2 | HIV positive non-smokers | |
| Cohort A3 | HIV negative smokers | |
| Cohort A4 | HIV negative non-smokers | |
| Cohort B1 | HIV positive with COPD | |
| Cohort B2 | HIV positive without COPD (non-COPD) | |
| Cohort B3 | HIV negative with COPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in immunoregulatory markers: PD-1 expression and interleukin (IL)-10 production by alveolar macrophages (AMs) from baseline to week 24.
Evaluate the immunoregulatory change between HIV positive (smokers/non-smokers) and HIV negative (smokers/non-smokers)
Measured: Baseline, Week 24
PD-1 expression and IL-10 production by AMs at baseline
Evaluate the association of PD-1 expression and IL-10 production by AMs after long-term antiretroviral therapy (ART) with abnormal lung function and a COPD phenotype between HIV positive (with and without COPD) and HIV negative with COPD.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionJul 2019
- Study completionDec 2019
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.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas B. Campbell, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02058719
- Sponsor's protocol ID
- 13-2986
- Status last verified
- Dec 2019
- First submitted
- 5 Feb 2014
- Last updated
- 18 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunosuppressive Effects of Smoking and HIV-1 on the Development of Lung Disease.
- ClinicalTrials.gov ID
- NCT02058719
- Acronym / sponsor ID
- 13-2986
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 10 Feb 2014 (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 plans to learn more about pulmonary complications of human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS). Even though antiretroviral therapy (ART) has dramatically decreased the number of opportunistic infections and deaths in HIV infected patients, pulmonary complications (including chronic obstructive pulmonary disease (COPD) development and pneumonias resulting in decreased lung function) of HIV/AIDS continue to be a major cause of morbidity and mortality in this population. The mechanisms underlying the increased risk of COPD and decreased lung function in HIV infected individuals is not well understand and needs to be studied.
The investigators hypothesize that the immunoregulatory consequences and immunosuppressive lung milieu secondary to HIV and cigarette smoke combine to increase the risk of lung infection and injury in HIV infected smokers, hastening the development of COPD. The mechanisms will be directly tested using blood and bronchial alveolar lavage (BAL) cells from smokers and nonsmokers with and without HIV infection.
Detailed description
The first component of this study will be a longitudinal, prospective, 24 weeks study of the effects of HIV-1 infection on innate and acquired immunity in the lung (Cohort A). The second component of this study will be a cross-sectional, case-control study of lung function and immune dysregulation of HIV-1 infected persons on long-term ART (Cohort B).
Cohort A will consist of 120 subjects, stratified by HIV-1 and smoking status
Cohort B will consist of 90 subjects stratified by chronic obstructive pulmonary disease (COPD) and HIV-1 infection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort A1 | – | –HIV positive smokers |
| Cohort A2 | – | –HIV positive non-smokers |
| Cohort A3 | – | –HIV negative smokers |
| Cohort A4 | – | –HIV negative non-smokers |
| Cohort B1 | – | –HIV positive with COPD |
| Cohort B2 | – | –HIV positive without COPD (non-COPD) |
| Cohort B3 | – | –HIV negative with COPD |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- HIV positive (smokers and non-smokers) and negative subjects (smokers and non-smokers) will be recruited. HIV positive (with and without COPD) and HIV negative with COPD will also be recruited. All subjects will be between ages 18 and 70.
Key inclusion criteria (11 listed)
- Subjects with chronic HIV-1 infection (Cohorts A1 and A2)
- ART naïve or off all ART for >6 months (Cohorts A1 and A2)
- HIV-1 RNA level >1,000 copies/ml (Cohorts A1 and A2)
- HIV-1 seronegative with no high-risk exposure in the past 30 days (Cohorts A3 and A4)
- 18 years and older (All Cohort A)
Key exclusion criteria (4 listed)
- Pregnancy
- Weight less than 110 pounds (for venipuncture)
- Patient inability to participate in the study and undergo venipuncture and bronchoscopy procedures
- Use of systemic or inhaled corticosteroids in the past 3 months.
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
The change in immunoregulatory markers: PD-1 expression and interleukin (IL)-10 production by alveolar macrophages (AMs) from baseline to week 24.
Time frame: Baseline, Week 24
Evaluate the immunoregulatory change between HIV positive (smokers/non-smokers) and HIV negative (smokers/non-smokers)
PD-1 expression and IL-10 production by AMs at baseline
Time frame: Baseline
Evaluate the association of PD-1 expression and IL-10 production by AMs after long-term antiretroviral therapy (ART) with abnormal lung function and a COPD phenotype between HIV positive (with and without COPD) and HIV negative with COPD.
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 18 Dec 2019.
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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.
Thomas B. Campbell, MD principal investigator
University of Colorado, Denver
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 Smoking, run by University of Colorado, Denver 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 11 inclusion and 4 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 18 Dec 2019. 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?
The change in immunoregulatory markers: PD-1 expression and interleukin (IL)-10 production by alveolar macrophages (AMs) from baseline to week 24. (time frame: Baseline, Week 24). The study lists 2 primary outcomes in all. 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 18 Dec 2019.