Pulmonary ComplicationsLHIVNCT00933595
Longitudinal Studies of HIV-Associated Lung Infections and Complications (Lung HIV)
A study testing Smoking Cessation in people with Pulmonary Complications and HIV Infections, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
The Lung HIV goal is to facilitate the data and specimen collection efforts of eight individual HIV and pulmonary studies that operate under the direction of the NHLBI. The Lung HIV study will build on existing studies to facilitate the start-up of new projects to further the understanding of the relationship between… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Complications, HIV Infections
- What is being tested?
- Smoking Cessation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Nov 2013
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women at the AIDS Clinical Trials Unit(ACTU) will be eligible to participate if they meet four criteria: (a) 18 years of age and older; and (b) diagnosis of HIV; and (c) self-reported smoking on a daily basis; and (d) provide informed written consent.
Who cannot join
- Persons who meet one or more of the following criteria will be excluded from the study: (a) persons with active psychosis or impaired mental status as judged by the clinic staff and confirmed with a Mini-Mental Status Exam); (b) unable to understand spoken English; (c) age less than 18 years.
- Rationale: Persons with cognitive impairment may participate in the study if they are able to provide consent and answer questionnaire questions. No reason is identified to exclude persons with this characteristic. No special risks are posed to cognitively impaired persons who are able to provide consent. Persons who have active psychoses or impaired mental status as judged by the clinic staff and confirmed with a Mini-Mental Status Exam are not able to provide informed written consent and are unlikely to benefit from the treatment. These persons will be referred to appropriate mental health services and invited to participate when their mental status has improved.
- Persons who are unable to understand spoken English would not be able to complete the assessments or benefit from the treatments. Less than 1% of the clinic population will be excluded on this basis. However, persons excluded from the study on this basis will be referred for standard smoking cessation treatment delivered in their native tongue. These community resources may be identified through the Ohio State University Nursing Center for Tobacco Intervention.
- Younger adolescents (<18 years) will not be invited to participate in the study because we believe that they require treatments that are qualitatively different from those designed for older adolescents and adults. The treatments that will be evaluated in the proposed research are well suited to older adolescents and adults, but not developmentally tailored to younger adolescents. Less than 1% of the clinic population will be excluded on this basis. Most HIV+ children living in Columbus, Ohio receive HIV medical care through the F.A.C.E.S. outpatient clinic at Columbus Children's Hospital. Standard, age appropriate, smoking cessation treatment is available through the Health and Wellness Center at Columbus Children's Hospital. In the unlikely circumstance that a child <18 years of age wishes to participate in the proposed study, s/he will be referred to Health and Wellness Center at Children's Hospital for treatment or the Ohio State University Nursing Center for Tobacco Intervention for age appropriate smoking cessation community resources.
- Pregnant women may not be included as subjects. While smoking during pregnancy is an important modifiable cause of poor pregnancy outcomes, little information is available on the safety or efficacy of varenicline. Therefore, participants who are pregnant will be excluded as subjects. Also, women who are breast-feeding will be excluded.
- Other persons who are unable to use varenicline will be allowed to participate in the study but will not receive the varenicline component of treatment. A history and physical examination will be conducted as a component of the baseline evaluation.
- People that have kidney problems or undergo kidney dialysis will not take the study drug, but will be given the option to take nicotine replacement therapy.
- All persons excluded from the study will have the opportunity to receive smoking cessation treatment. We will provide referrals for treatment as clinically indicated.
Trial locations and contacts
1 site in 1 country.
About this study
The Lung HIV goal is to facilitate the data and specimen collection efforts of eight individual HIV and pulmonary studies that operate under the direction of the NHLBI. The Lung HIV study will build on existing studies to facilitate the start-up of new projects to further the understanding of the relationship between pulmonary disease and HIV infection. There is only one clinical trial being performed in this network at Ohio State University and it will be reported here.
Read the detailed description
The Ohio State University Clinical Research Center (CRC), Patient Selection
Study Intervention Subjects:
365 HIV+ male and female smokers will be enrolled to the study and will be recruited over a two - four year period.
Inclusion criteria
- 18 years of age and older
- Diagnosis of HIV (Since the vast majority of our subjects will be recruited through the OSU Infectious disease clinics and HIV clinical research unit documentation of HIV status will not be a problem)
- Self-reported smoking (≥ 5 cigarettes per day to avoid inclusion of occasional, 'social' users and 'chippers');
- Able and willing to provide informed written consent.
Exclusion criteria:
- Inability to provide informed consent
- Inability to understand spoken English
- Currently diagnosed interstitial lung disease (i.e. sarcoidosis, idiopathic pulmonary fibrosis) or lung cancer.
Control Subjects Group A:
We will utilize normal subjects for the control study for the Diffusion Capacity of Lung for Carbon Monoxide (DLCO) and Diffusion capacity of Lung for Nitric Oxide (DLNO), recruited from the general population. We will recruit 5 males and 5 females in each decade of life from 21-30, 31-40, 41-50, 51-60, 61-70 (TOTAL= 50 subjects).
Inclusion criteria
- 21-70 years of age and older
- HIV Seronegative
- Able and willing to provide informed written consent.
Exclusion criteria:
- Inability to provide informed consent
- Inability to understand spoken English
- Current smoker or have smoked in the last 10 years or have a > 10 pack year history of smoking.
- Currently diagnosed interstitial lung disease (i.e. sarcoidosis, idiopathic pulmonary fibrosis) or lung cancer.
Control Subjects Group B:
We will utilize normal subjects for the control study for DLCO and DLNO, recruited from the general population. We will recruit 5 males and 5 females in each decade of life from 21-30, 31-40, 41-50, 51-60, 61-70 (TOTAL= 50 subjects).
Inclusion criteria
- 21-70 years of age and older
- HIV Seronegative
- Current or former smoker with at least a 5 pack year history of smoking
- Able and willing to provide informed written consent.
Exclusion criteria:
- Inability to provide informed consent
- Inability to understand spoken English
- Currently diagnosed interstitial lung disease (i.e. sarcoidosis, idiopathic pulmonary fibrosis) or lung cancer.
- Conditions
- Pulmonary Complications, HIV Infections
- Being tested
- Smoking Cessation
- Keywords
- HIV, Lung
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking CessationOther
A Motivational Interview session (~40-50 minutes) will be delivered by a trained nurse coordinator.
Treatment with varenicline (1 mg daily during week 1 (pre-quit week) followed by 1 mg twice daily for weeks 2-12)or nicotine replacement therapy (21 mg of a skin patch + nicotine gum 4 mg ad lib added for breakthrough craving up to 20 pieces/day.
| Study group | Role | What they receive |
|---|---|---|
| Smoking Cessation | Experimental | The overall smoking cessation rate for the intervention is 18.8 at 3 months, 13.1 at 6 months and 10.0 at 12 months. Receives: Other: Smoking Cessation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To develop and evaluate a specialized smoking cessation intervention for the treatment of nicotine dependence in HIV-seropositive smokers.
Measured: 5 years
Secondary outcomes (1)
To examine the effects of smoking cessation on the course of lung function decline, the prevalence of respiratory symptoms and the occurrence/progression of emphysema in a cohort of HIV-seropositive individuals.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2009 (estimated)
- Study startSep 2007
- Primary completionJun 2012
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary ComplicationsStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Johns Hopkins University, Johns Hopkins Bloomberg School of Public Health, New York University, Ohio State University, University of California, San Francisco, University of Colorado, Denver, University of Pittsburgh, University of Washington
- Responsible party
- Sponsor
- Investigators
- Hannah Peavy, MD, Study director, NHLBI Project Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00933595
- Sponsor's protocol ID
- 652
- Other IDs
- 3R01HL090331-05S1
- Acronym
- LHIV
- Status last verified
- Jan 2013
- First submitted
- 2 Jul 2009
- Last updated
- 1 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Crothers K, Thompson BW, Burkhardt K, Morris A, Flores SC, Diaz PT, Chaisson RE, Kirk GD, Rom WN, Huang L; Lung HIV Study. HIV-associated lung infections and complications in the era of combination antiretroviral therapy. Proc Am Thorac Soc. 2011 Jun;8(3):275-81. doi: 10.1513/pats.201009-059WR.
PubMed 21653528
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Studies of HIV-Associated Lung Infections and Complications (Lung HIV)
- ClinicalTrials.gov ID
- NCT00933595
- Acronym / sponsor ID
- LHIV / 652
- Conditions
- Pulmonary Complications, HIV Infections
- Keywords
- HIV, Lung
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Collaborators
- Johns Hopkins University, Johns Hopkins Bloomberg School of Public Health, New York University, Ohio State University, University of California, San Francisco, University of Colorado, Denver, University of Pittsburgh, University of Washington
- Study start
- Sep 2007
- Primary completion
- Jun 2012 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 7 Jul 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.
The Lung HIV goal is to facilitate the data and specimen collection efforts of eight individual HIV and pulmonary studies that operate under the direction of the NHLBI. The Lung HIV study will build on existing studies to facilitate the start-up of new projects to further the understanding of the relationship between pulmonary disease and HIV infection. There is only one clinical trial being performed in this network at Ohio State University and it will be reported here.
Detailed description
The Ohio State University Clinical Research Center (CRC), Patient Selection
Study Intervention Subjects:
365 HIV+ male and female smokers will be enrolled to the study and will be recruited over a two - four year period.
Inclusion criteria
- 18 years of age and older
- Diagnosis of HIV (Since the vast majority of our subjects will be recruited through the OSU Infectious disease clinics and HIV clinical research unit documentation of HIV status will not be a problem)
- Self-reported smoking (≥ 5 cigarettes per day to avoid inclusion of occasional, 'social' users and 'chippers');
- Able and willing to provide informed written consent.
Exclusion criteria:
- Inability to provide informed consent
- Inability to understand spoken English
- Currently diagnosed interstitial lung disease (i.e. sarcoidosis, idiopathic pulmonary fibrosis) or lung cancer.
Control Subjects Group A:
We will utilize normal subjects for the control study for the Diffusion Capacity of Lung for Carbon Monoxide (DLCO) and Diffusion capacity of Lung for Nitric Oxide (DLNO), recruited from the general population. We will recruit 5 males and 5 females in each decade of life from 21-30, 31-40, 41-50, 51-60, 61-70 (TOTAL= 50 subjects).
Inclusion criteria
- 21-70 years of age and older
- HIV Seronegative
- Able and willing to provide informed written consent.
Exclusion criteria:
- Inability to provide informed consent
- Inability to understand spoken English
- Current smoker or have smoked in the last 10 years or have a > 10 pack year history of smoking.
- Currently diagnosed interstitial lung disease (i.e. sarcoidosis, idiopathic pulmonary fibrosis) or lung cancer.
Control Subjects Group B:
We will utilize normal subjects for the control study for DLCO and DLNO, recruited from the general population. We will recruit 5 males and 5 females in each decade of life from 21-30, 31-40, 41-50, 51-60, 61-70 (TOTAL= 50 subjects).
Inclusion criteria
- 21-70 years of age and older
- HIV Seronegative
- Current or former smoker with at least a 5 pack year history of smoking
- Able and willing to provide informed written consent.
Exclusion criteria:
- Inability to provide informed consent
- Inability to understand spoken English
- Currently diagnosed interstitial lung disease (i.e. sarcoidosis, idiopathic pulmonary fibrosis) or lung cancer.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smoking Cessation | Experimental | Other: Smoking CessationThe overall smoking cessation rate for the intervention is 18.8 at 3 months, 13.1 at 6 months and 10.0 at 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women at the AIDS Clinical Trials Unit(ACTU) will be eligible to participate if they meet four criteria: (a) 18 years of age and older; and (b) diagnosis of HIV; and (c) self-reported smoking on a daily basis; and (d) provide informed written consent.
Key exclusion criteria (8 listed)
- Persons who meet one or more of the following criteria will be excluded from the study: (a) persons with active psychosis or impaired mental status as judged by the clinic staff and confirmed with a Mini-Mental Status Exam); (b) unable to understand spoken English; (c) age less than 18 years.
- Rationale: Persons with cognitive impairment may participate in the study if they are able to provide consent and answer questionnaire questions. No reason is identified to exclude persons with this characteristic. No special risks are posed to cognitively impaired persons who are able to provide consent. Persons who have active psychoses or impaired mental status as judged by the clinic staff and confirmed with a Mini-Mental Status Exam are not able to provide informed written consent and are unlikely to benefit from the treatment. These persons will be referred to appropriate mental health services and invited to participate when their mental status has improved.
- Persons who are unable to understand spoken English would not be able to complete the assessments or benefit from the treatments. Less than 1% of the clinic population will be excluded on this basis. However, persons excluded from the study on this basis will be referred for standard smoking cessation treatment delivered in their native tongue. These community resources may be identified through the Ohio State University Nursing Center for Tobacco Intervention.
- Younger adolescents (<18 years) will not be invited to participate in the study because we believe that they require treatments that are qualitatively different from those designed for older adolescents and adults. The treatments that will be evaluated in the proposed research are well suited to older adolescents and adults, but not developmentally tailored to younger adolescents. Less than 1% of the clinic population will be excluded on this basis. Most HIV+ children living in Columbus, Ohio receive HIV medical care through the F.A.C.E.S. outpatient clinic at Columbus Children's Hospital. Standard, age appropriate, smoking cessation treatment is available through the Health and Wellness Center at Columbus Children's Hospital. In the unlikely circumstance that a child <18 years of age wishes to participate in the proposed study, s/he will be referred to Health and Wellness Center at Children's Hospital for treatment or the Ohio State University Nursing Center for Tobacco Intervention for age appropriate smoking cessation community resources.
- Pregnant women may not be included as subjects. While smoking during pregnancy is an important modifiable cause of poor pregnancy outcomes, little information is available on the safety or efficacy of varenicline. Therefore, participants who are pregnant will be excluded as subjects. Also, women who are breast-feeding will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoking CessationA Motivational Interview session (~40-50 minutes) will be delivered by a trained nurse coordinator. Treatment with varenicline (1 mg daily during week 1 (pre-quit week) followed by 1 mg twice daily for weeks 2-12)or nicotine replacement therapy (21 mg of a skin patch + nicotine gum 4 mg ad lib added for breakthrough craving up to 20 pieces/day. | Other | Smoking Cessation |
Primary outcome
To develop and evaluate a specialized smoking cessation intervention for the treatment of nicotine dependence in HIV-seropositive smokers.
Time frame: 5 years
1 secondary outcome
To examine the effects of smoking cessation on the course of lung function decline, the prevalence of respiratory symptoms and the occurrence/progression of emphysema in a cohort of HIV-seropositive individuals.
Time frame: 5 years
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 Sep 2016.
- Derived from this study: PubMed 21653528Crothers K, Thompson BW, Burkhardt K, Morris A, Flores SC, Diaz PT, Chaisson RE, Kirk GD, Rom WN, Huang L; Lung HIV Study. HIV-associated lung infections and complications in the era of combination antiretroviral therapy. Proc Am Thorac Soc. 2011 Jun;8(3):275-81. doi: 10.1513/pats.201009-059WR.
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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.
Hannah Peavy, MD study director
NHLBI Project Officer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking Cessation in people with Pulmonary Complications and HIV Infections, run by National Heart, Lung, and Blood Institute (NHLBI) 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 1 inclusion and 8 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 Sep 2016. 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?
To develop and evaluate a specialized smoking cessation intervention for the treatment of nicotine dependence in HIV-seropositive smokers. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00933595, which also lists 1 linked publication.
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 Sep 2016.