AIDSNCT06137196
Risk Identification Factors for Pulmonary Function Impairment in AIDS Patients Recovered From Severe Pneumonia
An observational study of AIDS and Pneumonia, run by Guangzhou 8th People's Hospital at 1 site in China.
Trial summary
Screening for risk factors related to lung function impairment in patients who have recovered from AIDS with severe pneumonia, to provide clinical evidence for early identification and intervention of lung function damage in this population. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 1 Nov 2027
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All study participants come from the HIV/HBV co-infection cohort at the Guangzhou Eighth People's Hospital.
Who may be able to join
- Confirmed HIV infection;
- Progression to the AIDS stage: CD4+ count <200 cells/µL and/or occurrence of opportunistic infections associated with AIDS;
- Age between 18 to 65 years;
- Meet the diagnostic criteria for severe pneumonia, with reference to the 2021 treatment guidelines for community-acquired pneumonia developed by the American Thoracic Society (ATS) and the Infectious Diseases Society of America (IDSA).
Who cannot join
- Concurrent central nervous system lesions, severe liver disease, or cirrhosis;
- Concurrent AIDS-related or non-related tumors;
- Women who are pregnant or breastfeeding;
- Presence of serious underlying diseases such as heart, lung, liver, kidney, etc.;
- Alcohol abuse or drug use;
- The researcher believes that the overall condition of the subject affects the evaluation and completion of the trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangzhou Eighth People's Hospital, Guangzhou Medical University
Guangzhou, Guangdong, 510060
Linghua Li, PhD, +862083710825, llheliza@126.com
Yaozu He, Master, +862083710825, hyzdyl99@163.com
About this study
Official title: Study on Risk Identification Factors for Lung Function Impairment in AIDS Patients Recovered From Severe Pneumonia
Screening for risk factors related to lung function impairment in patients who have recovered from AIDS with severe pneumonia, to provide clinical evidence for early identification and intervention of lung function damage in this population.
Read the detailed description
This is a prospective, single-center, non-randomized, clinical observational cohort study. It involves monitoring lung function at discharge (baseline, 0w), and at the 4th, 8th, 12th, 24th, and 48th weeks in patients recovering from severe pneumonia with AIDS. Basic demographic data, HIV RNA quantification, routine blood tests, blood biochemistry, arterial blood gas results, oxygenation index, immune function (CD3+, CD4+, CD8+ T cell counts), and imaging studies are also collected. Multifactorial logistic regression analysis is used to screen for clinical predictors of lung function decline in patients recovering from severe pneumonia
- Keywords
- AIDS, Severe pneumonia, Lung function, Predictive factors
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Pneumonia
What is being measured
The primary outcome is the main question the study is designed to answer.
Obstructive Ventilatory Dysfunction
FEV1(Forced Expiratory Volume in One Second )to FVC (Forced Vital Capacity ) Ratio
Measured: 12 weeks
Secondary outcomes (1)
FEV1
FEV1 decrease of ≥100 mL
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Nov 2023
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AIDSStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou 8th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linghua LI, Guangzhou 8th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06137196
- Sponsor's protocol ID
- 202326263
- Status last verified
- Nov 2023
- First submitted
- 13 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Risk Identification Factors for Lung Function Impairment in AIDS Patients Recovered From Severe Pneumonia
- ClinicalTrials.gov ID
- NCT06137196
- Acronym / sponsor ID
- 202326263
- Keywords
- AIDS, Severe pneumonia, Lung function, Predictive factors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Guangzhou 8th People's HospitalUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 18 Nov 2023 (actual)
- 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.
Screening for risk factors related to lung function impairment in patients who have recovered from AIDS with severe pneumonia, to provide clinical evidence for early identification and intervention of lung function damage in this population.
Detailed description
This is a prospective, single-center, non-randomized, clinical observational cohort study. It involves monitoring lung function at discharge (baseline, 0w), and at the 4th, 8th, 12th, 24th, and 48th weeks in patients recovering from severe pneumonia with AIDS. Basic demographic data, HIV RNA quantification, routine blood tests, blood biochemistry, arterial blood gas results, oxygenation index, immune function (CD3+, CD4+, CD8+ T cell counts), and imaging studies are also collected. Multifactorial logistic regression analysis is used to screen for clinical predictors of lung function decline in patients recovering from severe pneumonia
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All study participants come from the HIV/HBV co-infection cohort at the Guangzhou Eighth People's Hospital.
Key inclusion criteria (4 listed)
- Confirmed HIV infection;
- Progression to the AIDS stage: CD4+ count <200 cells/µL and/or occurrence of opportunistic infections associated with AIDS;
- Age between 18 to 65 years;
- Meet the diagnostic criteria for severe pneumonia, with reference to the 2021 treatment guidelines for community-acquired pneumonia developed by the American Thoracic Society (ATS) and the Infectious Diseases Society of America (IDSA).
Key exclusion criteria (6 listed)
- Concurrent central nervous system lesions, severe liver disease, or cirrhosis;
- Concurrent AIDS-related or non-related tumors;
- Women who are pregnant or breastfeeding;
- Presence of serious underlying diseases such as heart, lung, liver, kidney, etc.;
- Alcohol abuse or drug use;
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
Obstructive Ventilatory Dysfunction
Time frame: 12 weeks
FEV1(Forced Expiratory Volume in One Second )to FVC (Forced Vital Capacity ) Ratio
1 secondary outcome
FEV1
Time frame: 12 weeks
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 18 Nov 2023.
- Individual participant dataSharing planned: No
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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.
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 AIDS and Pneumonia, run by Guangzhou 8th People's Hospital at 1 site in China.
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 6 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: looking for participants now, as of the sponsor's last update on 18 Nov 2023. 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 China. 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?
Contact Linghua Li, PhD (+862083710825, llheliza@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obstructive Ventilatory Dysfunction (time frame: 12 weeks). 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 Nov 2023.