HIVCOCOMONCT02382822
Copenhagen Comorbidity in HIV Infection Study
An observational study of HIV and COPD, run by Susanne Dam Nielsen, MD, DMSc at 2 sites in Denmark.
Trial summary
Despite efficient antiretroviral treatment for HIV infection, decrease in life expectancy remains. Excess mortality is mainly due to non-AIDS co-morbidity including cardiovascular, pulmonary, and liver related diseases. Both HIV-unrelated and HIV-related risk factors probably contribute to this pattern. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- How many people
- 1,099 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Feb 2015to 31 Dec 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV infected patients.
Who may be able to join
- signed informed consent
- HIV infected
- aged 20-100 years
Who cannot join
- patients that are unable to understand information material
- Computed tomography (CT):
- contraindications to CT and contrast (i.e. pregnancy, renal impairment, allergy to contrast media, allergy or contraindication to beta blocking agent, body weight more than 120kg, evidence of ongoing myocardial ischemia, heart rhythm precluding EKG gating)
- Spirometry:
- relative contraindications to spirometry (i.e. chest, abdominal or eye surgery within the 3 months before baseline spirometry, and known retinal detachment)
- allergy or contraindications to salbutamol (i.e. >110 bpm, or a known uncontrolled cardiac condition (i.e. unstable coronary artery disease, decompensated heart failure)
Show all 14Show fewer
- a respiratory illness with at least two symptoms of breathlessness, cough, wheezing, or increase in sputum production within 6 weeks.
- MRI:
- Implants (e.g. pacemaker, coclea implants, insulin pumps)
- Claustrophobia
- Pregnancy
- Liver Biopsy:
- Risk of bleeding
- Infection in puncture site
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Copenhagen University Hospital - Rigshospitalet
Copenhagen, 2100
Copenhagen University Hospital - Amager and Hvidovre
Hvidovre
About this study
Despite efficient antiretroviral treatment for HIV infection, decrease in life expectancy remains. Excess mortality is mainly due to non-AIDS co-morbidity including cardiovascular, pulmonary, and liver related diseases. Both HIV-unrelated and HIV-related risk factors probably contribute to this pattern. At present, most evidence regarding co-morbidity in HIV infection rely on cross-study comparisons of HIV-infected persons with published population rates and few prospective studies in U.S. cohorts. Using well characterized participants from the Copenhagen General Population Study (CGPS) as controls, we aim to include >1500 HIV-infected persons in the COCOMO study to determine if co-morbidity is more prevalent or develops at a higher rate in HIV-infected persons. The study will asses 1) cardiovascular, 2) pulmonary and 3) liver-related co-morbidity using uniformly collected data in the two cohorts. The investigators aim to study the relative impact of HIV-unrelated and HIV-related factors on development of co-morbidity.
Read the detailed description
Primary hypothesis:
Cardiovascular disease:
- HIV infection is independently associated with higher prevalence of coronary atherosclerosis (assessed by CT angiography)
Obstructive pulmonary disease:
- HIV infection is independently associated with higher prevalence of COPD, and independently associated with loss of lung function
Liver disease:
- HIV infection is independently associated with liver steatosis, steatohepatitis and liver fibrosis
Lipid and fat metabolism:
- HIV infection is independently associated with alterations in adipose fat tissue and dyslipidemia
Secondary hypothesis:
Cardiovascular disease:
- Viral load and CD4 are independently associated with coronary atherosclerosis (assessed by CT angiography) in HIV-infected individuals.
- Levels of inflammatory markers can predict coronary atherosclerosis in HIV-infected individuals.
- Microbial translocation and metabolism are associated with coronary atherosclerosis in HIV-infected individuals.
- Endothelial dysfunction (assessed by arterial elastography) can predict coronary atherosclerosis in HIV-infected individuals
Obstructive pulmonary disease:
- Viral load and CD4 is independently associated with emphysema
- HIV is independently associated with pulmonary hypertension (assessed by CT angiography), and obstructive lung disease is independently associated with airway obstruction
- PCP colonization in HIV infected patients is independently associated with obstructive lung disease, emphysema and loss of lung function.
- Inflammatory markers in HIV infected patients are associated with obstructive lung disease and loss of lung function
- Conditions
- HIV, COPD, CVD, Liver Disease
- Being tested
- No intervention.
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention.Other
| Study group | Role | What they receive |
|---|---|---|
| HIV infected | Exposure to: Computed tomography(CT) of chest and upper abdomen, CT angiography(CTa) of heart, spirometry, mouth wash, eNO assessment, ankle brachial pressure index, fibroscan, blood sampling Receives: Other: No intervention. | |
| HIV uninfected | Exposure to: Computed tomography(CT) of chest and upper abdomen, CT angiography(CTa) of heart, spirometry, eNO assessment, ankle brachial pressure index, blood sampling Receives: Other: No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary atherosclerosis
Prevalence of coronary atherosclerosis; electrocardiographic abnormalities and peripheral artery disease
Measured: Baseline cross-sectional data and after 2 years follow-up
Obstructive pulmonary disease
Emphysema, airflow limitation,
Measured: Baseline cross-sectional data and after 2 years follow-up
Liver disease
Prevalence of hepatic steatosis, steatohepatitis and liver fibrosis
Measured: Baseline cross-sectional data and after 2 years follow-up
Lipid and fat metabolism
Visceral adipose tissue, dyslipidemia, gut microbiota
Measured: Baseline cross-sectional data and after 2 years follow-up
Inflammation and clonal hematopoiesis
Cytokines (e.g. IL-6, TNF-alfa), cell subsets (e.g. Tregs, Th17)
Measured: Baseline cross-sectional data and after 2 years follow-up
Secondary outcomes (5)
Emphysema, P. jirovecii colonization
Secondary pulmonary outcome measures
Measured: Baseline data(cross-sectional data)
Depression
Major Depression Inventory Score, kynurenin/tryptophan ratio
Measured: Baseline data (cross-sectional data)
Bone metabolism
Bone mineral density
Measured: Baseline data(cross-sectional data) assessed after two years
Hematological abnormalities
Anemia, trombocytopenia, leukopenia
Measured: Baseline data(cross-sectional data)
Renal function
Kidney function
Measured: Baseline data(cross-sectional data)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study start1 Feb 2015
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,099 participants (actual)
Sponsor and investigators
- Lead sponsor
- Susanne Dam Nielsen, MD, DMSc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Susanne Dam Nielsen, MD, DMSc, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Susanne D Nielsen, Professor, MD, DMSc, Principal investigator, Department of Infectious Diseases, Copenhagen University Hospital - RigshospitaletThomas L Benfield, Professor, MD, DMSc, Study director, Department of Infectious Diseases, Copenhagen University Hospital - Amager and HvidovreKlaus F Kofoed, Professor, MD, PhD, DMSc, Study director, Department of Cardiology, Copenhagen University Hospital - RigshospitaletLars V Køber, Professor, MD, PhD, DMSc, Study director, Department of Cardiology, Copenhagen University Hospital - RigshospitaletBørge G Nordestgaard, Professor, MD, DMSc, Study director, Department of Clinical Biochemistry, Copenhagen University Hospital - Herlev and GentofteShoaib Afzal, Professor, MD, DMSc, Study director, Department of Clinical Biochemistry, Copenhagen University Hospital - Herlev and Gentofte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02382822
- Sponsor's protocol ID
- H-8-2014-004
- Acronym
- COCOMO
- Status last verified
- Aug 2026
- First submitted
- 3 Mar 2015
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Heidari SL, Loft JA, Colak Y, Afzal S, Nordestgaard BG, Benfield T, Kunisaki KM, Nielsen SD, Ronit A. Prevalence and Risk Factors of Preserved Ratio Impaired Spirometry in People With HIV and Matched Population Control Participants. Chest. 2026 Jun 18:S0012-3692(26)00871-8. doi: 10.1016/j.chest.2026.05.044. Online ahead of print.
PubMed 42314937Stoltz TT, Jensen AMR, Roed AKH, Frikke-Schmidt R, Knudsen AD, Suarez-Zdunek MA, Benfield T, Nordestgaard BG, Kamstrup PR, Ostrowski SR, Tr Seid M, Afzal S, Nielsen SD. Plasma levels of lipoprotein(a) in persons with HIV compared to the general population. AIDS. 2026 Jan 1;40(1):35-42. doi: 10.1097/QAD.0000000000004349. Epub 2025 Sep 18.
PubMed 40971414Thudium RF, Ringheim H, Ronit A, Hoel H, Benfield T, Mocroft A, Gerstoft J, Troseid M, Borges AH, Ostrowski SR, Vestbo J, Nielsen SD. Independent Associations of Tumor Necrosis Factor-Alpha and Interleukin-1 Beta With Radiographic Emphysema in People Living With HIV. Front Immunol. 2021 Apr 14;12:668113. doi: 10.3389/fimmu.2021.668113. eCollection 2021.
PubMed 33936110Kirkegaard-Klitbo DM, Thomsen MT, Gelpi M, Bendtsen F, Nielsen SD, Benfield T. Hepatic Steatosis Associated With Exposure to Elvitegravir and Raltegravir. Clin Infect Dis. 2021 Aug 2;73(3):e811-e814. doi: 10.1093/cid/ciab057.
PubMed 33493297Ronit A, Lundgren J, Afzal S, Benfield T, Roen A, Mocroft A, Gerstoft J, Nordestgaard BG, Vestbo J, Nielsen SD; Copenhagen Co-morbidity in HIV infection (COCOMO) study group. Airflow limitation in people living with HIV and matched uninfected controls. Thorax. 2018 May;73(5):431-438. doi: 10.1136/thoraxjnl-2017-211079. Epub 2018 Jan 13.
PubMed 29331988Ronit A, Kristensen T, Klitbo DM, Gelpi M, Kalhauge A, Benfield T, Gerstoft J, Lundgren J, Vestbo J, Kofoed KF, Nielsen SD. Incidental lung cancers and positive computed tomography images in people living with HIV. AIDS. 2017 Sep 10;31(14):1973-1977. doi: 10.1097/QAD.0000000000001600.
PubMed 28857778Ronit A, Mathiesen IH, Gelpi M, Benfield T, Gerstoft J, Pressler T, Christiansen A, Lundgren J, Vestbo J, Dam Nielsen S. Small airway dysfunction in well-treated never-smoking HIV-infected individuals. Eur Respir J. 2017 Mar 2;49(3):1602186. doi: 10.1183/13993003.02186-2016. Print 2017 Mar. No abstract available.
PubMed 28254767Ronit A, Haissman J, Kirkegaard-Klitbo DM, Kristensen TS, Lebech AM, Benfield T, Gerstoft J, Ullum H, Kober L, Kjaer A, Kofoed K, Vestbo J, Nordestgaard B, Lundgren J, Nielsen SD. Copenhagen comorbidity in HIV infection (COCOMO) study: a study protocol for a longitudinal, non-interventional assessment of non-AIDS comorbidity in HIV infection in Denmark. BMC Infect Dis. 2016 Nov 26;16(1):713. doi: 10.1186/s12879-016-2026-9.
PubMed 27887644
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Copenhagen Comorbidity in HIV Infection Study
- ClinicalTrials.gov ID
- NCT02382822
- Acronym / sponsor ID
- COCOMO / H-8-2014-004
- Conditions
- HIV, COPD, CVD, Liver Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,099 participants (actual)
- Lead sponsor
- Susanne Dam Nielsen, MD, DMScUniversity, hospital or other
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 9 Mar 2015 (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.
Despite efficient antiretroviral treatment for HIV infection, decrease in life expectancy remains. Excess mortality is mainly due to non-AIDS co-morbidity including cardiovascular, pulmonary, and liver related diseases. Both HIV-unrelated and HIV-related risk factors probably contribute to this pattern. At present, most evidence regarding co-morbidity in HIV infection rely on cross-study comparisons of HIV-infected persons with published population rates and few prospective studies in U.S. cohorts. Using well characterized participants from the Copenhagen General Population Study (CGPS) as controls, we aim to include >1500 HIV-infected persons in the COCOMO study to determine if co-morbidity is more prevalent or develops at a higher rate in HIV-infected persons. The study will asses 1) cardiovascular, 2) pulmonary and 3) liver-related co-morbidity using uniformly collected data in the two cohorts. The investigators aim to study the relative impact of HIV-unrelated and HIV-related factors on development of co-morbidity.
Detailed description
Primary hypothesis:
Cardiovascular disease:
- HIV infection is independently associated with higher prevalence of coronary atherosclerosis (assessed by CT angiography)
Obstructive pulmonary disease:
- HIV infection is independently associated with higher prevalence of COPD, and independently associated with loss of lung function
Liver disease:
- HIV infection is independently associated with liver steatosis, steatohepatitis and liver fibrosis
Lipid and fat metabolism:
- HIV infection is independently associated with alterations in adipose fat tissue and dyslipidemia
Secondary hypothesis:
Cardiovascular disease:
- Viral load and CD4 are independently associated with coronary atherosclerosis (assessed by CT angiography) in HIV-infected individuals.
- Levels of inflammatory markers can predict coronary atherosclerosis in HIV-infected individuals.
- Microbial translocation and metabolism are associated with coronary atherosclerosis in HIV-infected individuals.
- Endothelial dysfunction (assessed by arterial elastography) can predict coronary atherosclerosis in HIV-infected individuals
Obstructive pulmonary disease:
- Viral load and CD4 is independently associated with emphysema
- HIV is independently associated with pulmonary hypertension (assessed by CT angiography), and obstructive lung disease is independently associated with airway obstruction
- PCP colonization in HIV infected patients is independently associated with obstructive lung disease, emphysema and loss of lung function.
- Inflammatory markers in HIV infected patients are associated with obstructive lung disease and loss of lung function
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV infected | – | Other: No intervention.Exposure to: Computed tomography(CT) of chest and upper abdomen, CT angiography(CTa) of heart, spirometry, mouth wash, eNO assessment, ankle brachial pressure index, fibroscan, blood sampling |
| HIV uninfected | – | Other: No intervention.Exposure to: Computed tomography(CT) of chest and upper abdomen, CT angiography(CTa) of heart, spirometry, eNO assessment, ankle brachial pressure index, blood sampling |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV infected patients.
Key inclusion criteria (3 listed)
- signed informed consent
- HIV infected
- aged 20-100 years
Key exclusion criteria (14 listed)
- patients that are unable to understand information material
- contraindications to CT and contrast (i.e. pregnancy, renal impairment, allergy to contrast media, allergy or contraindication to beta blocking agent, body weight more than 120kg, evidence of ongoing myocardial ischemia, heart rhythm precluding EKG gating)
- relative contraindications to spirometry (i.e. chest, abdominal or eye surgery within the 3 months before baseline spirometry, and known retinal detachment)
- allergy or contraindications to salbutamol (i.e. >110 bpm, or a known uncontrolled cardiac condition (i.e. unstable coronary artery disease, decompensated heart failure)
- a respiratory illness with at least two symptoms of breathlessness, cough, wheezing, or increase in sputum production within 6 weeks.
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 |
|---|---|---|
| No intervention. | Other | HIV infected, HIV uninfected |
Primary outcome
Coronary atherosclerosis
Time frame: Baseline cross-sectional data and after 2 years follow-up
Prevalence of coronary atherosclerosis; electrocardiographic abnormalities and peripheral artery disease
Obstructive pulmonary disease
Time frame: Baseline cross-sectional data and after 2 years follow-up
Emphysema, airflow limitation,
Liver disease
Time frame: Baseline cross-sectional data and after 2 years follow-up
Prevalence of hepatic steatosis, steatohepatitis and liver fibrosis
Lipid and fat metabolism
Time frame: Baseline cross-sectional data and after 2 years follow-up
Visceral adipose tissue, dyslipidemia, gut microbiota
Inflammation and clonal hematopoiesis
Time frame: Baseline cross-sectional data and after 2 years follow-up
Cytokines (e.g. IL-6, TNF-alfa), cell subsets (e.g. Tregs, Th17)
5 secondary outcomes
Emphysema, P. jirovecii colonization
Time frame: Baseline data(cross-sectional data)
Depression
Time frame: Baseline data (cross-sectional data)
Bone metabolism
Time frame: Baseline data(cross-sectional data) assessed after two years
Hematological abnormalities
Time frame: Baseline data(cross-sectional data)
Renal function
Time frame: Baseline data(cross-sectional data)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Derived from this study: PubMed 42314937Heidari SL, Loft JA, Colak Y, Afzal S, Nordestgaard BG, Benfield T, Kunisaki KM, Nielsen SD, Ronit A. Prevalence and Risk Factors of Preserved Ratio Impaired Spirometry in People With HIV and Matched Population Control Participants. Chest. 2026 Jun 18:S0012-3692(26)00871-8. doi: 10.1016/j.chest.2026.05.044. Online ahead of print.
- Derived from this study: PubMed 40971414Stoltz TT, Jensen AMR, Roed AKH, Frikke-Schmidt R, Knudsen AD, Suarez-Zdunek MA, Benfield T, Nordestgaard BG, Kamstrup PR, Ostrowski SR, Tr Seid M, Afzal S, Nielsen SD. Plasma levels of lipoprotein(a) in persons with HIV compared to the general population. AIDS. 2026 Jan 1;40(1):35-42. doi: 10.1097/QAD.0000000000004349. Epub 2025 Sep 18.
- Derived from this study: PubMed 33936110Thudium RF, Ringheim H, Ronit A, Hoel H, Benfield T, Mocroft A, Gerstoft J, Troseid M, Borges AH, Ostrowski SR, Vestbo J, Nielsen SD. Independent Associations of Tumor Necrosis Factor-Alpha and Interleukin-1 Beta With Radiographic Emphysema in People Living With HIV. Front Immunol. 2021 Apr 14;12:668113. doi: 10.3389/fimmu.2021.668113. eCollection 2021.
- Derived from this study: PubMed 33493297Kirkegaard-Klitbo DM, Thomsen MT, Gelpi M, Bendtsen F, Nielsen SD, Benfield T. Hepatic Steatosis Associated With Exposure to Elvitegravir and Raltegravir. Clin Infect Dis. 2021 Aug 2;73(3):e811-e814. doi: 10.1093/cid/ciab057.
- Derived from this study: PubMed 29331988Ronit A, Lundgren J, Afzal S, Benfield T, Roen A, Mocroft A, Gerstoft J, Nordestgaard BG, Vestbo J, Nielsen SD; Copenhagen Co-morbidity in HIV infection (COCOMO) study group. Airflow limitation in people living with HIV and matched uninfected controls. Thorax. 2018 May;73(5):431-438. doi: 10.1136/thoraxjnl-2017-211079. Epub 2018 Jan 13.
- Derived from this study: PubMed 28857778Ronit A, Kristensen T, Klitbo DM, Gelpi M, Kalhauge A, Benfield T, Gerstoft J, Lundgren J, Vestbo J, Kofoed KF, Nielsen SD. Incidental lung cancers and positive computed tomography images in people living with HIV. AIDS. 2017 Sep 10;31(14):1973-1977. doi: 10.1097/QAD.0000000000001600.
- Derived from this study: PubMed 28254767Ronit A, Mathiesen IH, Gelpi M, Benfield T, Gerstoft J, Pressler T, Christiansen A, Lundgren J, Vestbo J, Dam Nielsen S. Small airway dysfunction in well-treated never-smoking HIV-infected individuals. Eur Respir J. 2017 Mar 2;49(3):1602186. doi: 10.1183/13993003.02186-2016. Print 2017 Mar. No abstract available.
- Derived from this study: PubMed 27887644Ronit A, Haissman J, Kirkegaard-Klitbo DM, Kristensen TS, Lebech AM, Benfield T, Gerstoft J, Ullum H, Kober L, Kjaer A, Kofoed K, Vestbo J, Nordestgaard B, Lundgren J, Nielsen SD. Copenhagen comorbidity in HIV infection (COCOMO) study: a study protocol for a longitudinal, non-interventional assessment of non-AIDS comorbidity in HIV infection in Denmark. BMC Infect Dis. 2016 Nov 26;16(1):713. doi: 10.1186/s12879-016-2026-9.
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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.
Susanne D Nielsen, Professor, MD, DMSc principal investigator
Department of Infectious Diseases, Copenhagen University Hospital - Rigshospitalet
Thomas L Benfield, Professor, MD, DMSc study director
Department of Infectious Diseases, Copenhagen University Hospital - Amager and Hvidovre
Klaus F Kofoed, Professor, MD, PhD, DMSc study director
Department of Cardiology, Copenhagen University Hospital - Rigshospitalet
2 sites 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 COPD, run by Susanne Dam Nielsen, MD, DMSc at 2 sites in Denmark.
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 14 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: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
This study is still under way. Results are not available in the source record yet.
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?
Coronary atherosclerosis (time frame: Baseline cross-sectional data and after 2 years follow-up). The study lists 5 primary outcomes in all. 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 NCT02382822, which also lists 8 linked publications.
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 12 Aug 2026.