HIV InfectionsHIV&COPDNCT00904384
Prevalence and Determinants of Chronic Obstructive Pulmonary Disease (COPD) in HIV+ Patients
An observational study of HIV Infections and COPD, run by Cimera at 1 site in Spain.
Trial summary
The prevalence of COPD in HIV+ and AIDS patients is unknown. The pathophysiology of HIV infection and COPD might be of interest to both conditions. The research hypotheses of this study are: In patients with HIV infection living in the Autonomous Community of the Balearic Islands (CAIB): 1. Read more about this study
- Who is it for?
- Ages 40 to 69 years
- Conditions the study is for
- HIV Infections, COPD
- How many people
- 350 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2008to Jan 2011
- 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 40 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited from the HIV outpatient consultation of the Internal Medicine Department of Hospital Universitario Son Dureta (HUSD), in Mallorca, Spain. The HUSD is the tertiary, reference hospital in the CAIB.
Who may be able to join
- HIV infection in stable phase (minimum of three months)
- Being followed-up in external HUSD consultations (on a regular basis)
- Age 40-69 years
Who cannot join
- Chronic non-respiratory disease in terminal stage (stage IV or V of chronic kidney failure, heart failure, advanced chronic liver disease (Child C))
- Lack of cooperation
- Estimated survival of less than 1 year or Karnofsky <70
- Pregnancy
- Opportunistic infection in the last month
- Post lung resection
- Systemic treatment with corticosteroids, immunosuppressive chemotherapy or interferon at the time of inclusion
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Son Dureta
Palma de Mallorca, Balearic Islands, 07014
About this study
Official title: Prevalencia, Factores de Riesgo y características patogénicas Diferenciales de EPOC y Enfisema en Pacientes Con infección VIH.
The prevalence of COPD in HIV+ and AIDS patients is unknown. The pathophysiology of HIV infection and COPD might be of interest to both conditions. The research hypotheses of this study are:
In patients with HIV infection living in the Autonomous Community of the Balearic Islands (CAIB):
- The Prevalence of airflow obstruction in patients with HIV infection is higher than in the general population.
- In these patients, the prevalence of emphysema detected by HRCT is common (greater than or equal to 15%)
- DLCO measurement is a good marker for the presence of emphysema on CT
- The inflammatory response is different from that seen in patients with COPD and / or emphysema without HIV infection
Read the detailed description
Objectives
Main objective To determine the prevalence of COPD
Secondary objectives
- To determine the prevalence (and severity) of emphysema (HRCT)
- To Identify risk factors associated with the development of COPD and / or emphysema
- To analyze the predictive value of measuring DLCO as a marker of emphysema by HRCT
- To determine the prevalence of lung function abnormalities deeming specific drug treatment (bronchodilators, inhaled corticosteroids) in the absence of clinical symptoms
- To compare the pattern of inflammatory response in patients with COPD and / or emphysema, with and without HIV infection
Methodology:
Cross-sectional, descriptive, study of up to 350 patients with HIV infection.
All the patients will be be assessed with:
- an standardized clinical questionnaire
- full lung function tests
- high resolution CT scan
- induced sputum for bacterial culture, P. jiroveci, proinflamatory citokines (cytokines array)
- blood analysis: hemogram; basic biochemistry; HIV predictors; autoantibodies; proinflammatory citokines (ultrasensitive ELISA); C reactive protein (ultrasensitive nephelometry)
- exhaled gases (NO and CO)
Statistical analysis:
Description of the univariate distribution of the categorical or ordinal variables will be realized with a table of frequencies, and in quantitative variables by means of measures of central tendency (mean or median) and dispersion (standard deviation or 95 % confidence intervals). Depending on the normality of the distribution of variables, any comparisons will be assessed by means of parametric tests (T test; Chi2) or non parametric tests (Mann Whitney). To explore relationships between the variables of study, Kolgomorov-Smirnov for the comparison of groups and analysis of regression bivariate, and multivariate (logistic regression), will be conducted.
- Conditions
- HIV Infections, COPD
- Keywords
- HIV+, COPD, emphysema
- Medical subject headings
- HIV Infections, Pulmonary Disease, Chronic Obstructive, Emphysema
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 |
|---|---|---|
| HIV+ | Patients with HIV infection living in the Autonomous Community of the Balearic Islands (CAIB), Spain | |
| Reference group | Same determinations as in HIV+ cases will be obtained in the control group of COPD patients without HIV infection as part of the study PAC-EPOC (FIS 05/2082) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of airflow obstruction compatible with COPD in patients with HIV infection
Measured: cross-sectional
Secondary outcomes (5)
To determine the prevalence (and severity) of emphysema (HRCT)
Measured: Cross-sectional
To Identify risk factors associated with the development of COPD and / or emphysema
Measured: Cross-sectional
To analyze the predictive value of measuring DLCO as a marker of emphysema by HRCT
Measured: Cross-sectional
To determine the prevalence of lung function abnormalities deeming specific drug treatment (bronchodilators, inhaled corticosteroids) in the absence of clinical symptoms
Measured: Cross-sectional
To compare the pattern of inflammatory response in patients with COPD and / or emphysema, with and without HIV infection
Measured: Cross-sectional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2009 (estimated)
- Study startJul 2008
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cimera
- Sponsor type
- Research network
- Collaborators
- Hospital Universitari Son Dureta
- Investigators
- Melchor Riera, MD, Principal investigator, Hospital Universitario Son Dureta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00904384
- Sponsor's protocol ID
- IB956/08 IP
- Acronym
- HIV&COPD
- Status last verified
- Jun 2011
- First submitted
- 15 May 2009
- Last updated
- 10 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalencia, Factores de Riesgo y características patogénicas Diferenciales de EPOC y Enfisema en Pacientes Con infección VIH.
- ClinicalTrials.gov ID
- NCT00904384
- Acronym / sponsor ID
- HIV&COPD / IB956/08 IP
- Conditions
- HIV Infections, COPD
- Keywords
- HIV+, COPD, emphysema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- CimeraResearch network
- Collaborators
- Hospital Universitari Son Dureta
- Study start
- Jul 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 19 May 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 prevalence of COPD in HIV+ and AIDS patients is unknown. The pathophysiology of HIV infection and COPD might be of interest to both conditions. The research hypotheses of this study are:
In patients with HIV infection living in the Autonomous Community of the Balearic Islands (CAIB):
- The Prevalence of airflow obstruction in patients with HIV infection is higher than in the general population.
- In these patients, the prevalence of emphysema detected by HRCT is common (greater than or equal to 15%)
- DLCO measurement is a good marker for the presence of emphysema on CT
- The inflammatory response is different from that seen in patients with COPD and / or emphysema without HIV infection
Detailed description
Objectives
Main objective To determine the prevalence of COPD
Secondary objectives
- To determine the prevalence (and severity) of emphysema (HRCT)
- To Identify risk factors associated with the development of COPD and / or emphysema
- To analyze the predictive value of measuring DLCO as a marker of emphysema by HRCT
- To determine the prevalence of lung function abnormalities deeming specific drug treatment (bronchodilators, inhaled corticosteroids) in the absence of clinical symptoms
- To compare the pattern of inflammatory response in patients with COPD and / or emphysema, with and without HIV infection
Methodology:
Cross-sectional, descriptive, study of up to 350 patients with HIV infection.
All the patients will be be assessed with:
- an standardized clinical questionnaire
- full lung function tests
- high resolution CT scan
- induced sputum for bacterial culture, P. jiroveci, proinflamatory citokines (cytokines array)
- blood analysis: hemogram; basic biochemistry; HIV predictors; autoantibodies; proinflammatory citokines (ultrasensitive ELISA); C reactive protein (ultrasensitive nephelometry)
- exhaled gases (NO and CO)
Statistical analysis:
Description of the univariate distribution of the categorical or ordinal variables will be realized with a table of frequencies, and in quantitative variables by means of measures of central tendency (mean or median) and dispersion (standard deviation or 95 % confidence intervals). Depending on the normality of the distribution of variables, any comparisons will be assessed by means of parametric tests (T test; Chi2) or non parametric tests (Mann Whitney). To explore relationships between the variables of study, Kolgomorov-Smirnov for the comparison of groups and analysis of regression bivariate, and multivariate (logistic regression), will be conducted.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV+ | – | –Patients with HIV infection living in the Autonomous Community of the Balearic Islands (CAIB), Spain |
| Reference group | – | –Same determinations as in HIV+ cases will be obtained in the control group of COPD patients without HIV infection as part of the study PAC-EPOC (FIS 05/2082) |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from the HIV outpatient consultation of the Internal Medicine Department of Hospital Universitario Son Dureta (HUSD), in Mallorca, Spain. The HUSD is the tertiary, reference hospital in the CAIB.
Key inclusion criteria (3 listed)
- HIV infection in stable phase (minimum of three months)
- Being followed-up in external HUSD consultations (on a regular basis)
- Age 40-69 years
Key exclusion criteria (7 listed)
- Chronic non-respiratory disease in terminal stage (stage IV or V of chronic kidney failure, heart failure, advanced chronic liver disease (Child C))
- Lack of cooperation
- Estimated survival of less than 1 year or Karnofsky <70
- Pregnancy
- Opportunistic infection in the last month
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
Prevalence of airflow obstruction compatible with COPD in patients with HIV infection
Time frame: cross-sectional
5 secondary outcomes
To determine the prevalence (and severity) of emphysema (HRCT)
Time frame: Cross-sectional
To Identify risk factors associated with the development of COPD and / or emphysema
Time frame: Cross-sectional
To analyze the predictive value of measuring DLCO as a marker of emphysema by HRCT
Time frame: Cross-sectional
To determine the prevalence of lung function abnormalities deeming specific drug treatment (bronchodilators, inhaled corticosteroids) in the absence of clinical symptoms
Time frame: Cross-sectional
To compare the pattern of inflammatory response in patients with COPD and / or emphysema, with and without HIV infection
Time frame: Cross-sectional
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 10 Jun 2011.
- Hospital Universitario Son DuretaLink provided by the sponsor.
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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.
Melchor Riera, MD principal investigator
Hospital Universitario Son Dureta
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 Infections and COPD, run by Cimera at 1 site in Spain.
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 3 inclusion and 7 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 10 Jun 2011. 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 Spain. 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?
Prevalence of airflow obstruction compatible with COPD in patients with HIV infection (time frame: cross-sectional). 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 10 Jun 2011.