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RecruitingNCT06137196Updated Nov 18, 2023

Risk Identification Factors for Pulmonary Function Impairment in AIDS Patients Recovered From Severe Pneumonia

An observational study in AIDS and Pneumonia, sponsored by Guangzhou 8th People's Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-11-18.

Sponsored by Guangzhou 8th People's Hospital · Observational

From the registry’s dates

  • Started Nov 2023; still recruiting 2 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 65 Years
Sex
All
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Study 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 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

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Conditions studied

  • AIDS
  • Pneumonia

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Keywords

  • AIDS
  • Severe pneumonia
  • Lung function
  • Predictive factors
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In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's planned enrollment of 100 is below the median of 203 across 688 observational studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Guangzhou 8th People's Hospital is the lead sponsor of 16 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All study participants come from the HIV/HBV co-infection cohort at the Guangzhou Eighth People's Hospital.

Inclusion criteria

  1. Confirmed HIV infection;
  2. Progression to the AIDS stage: CD4+ count \<200 cells/µL and/or occurrence of opportunistic infections associated with AIDS;
  3. Age between 18 to 65 years;
  4. 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).

Exclusion criteria

Exclusion Criteria:

  1. Concurrent central nervous system lesions, severe liver disease, or cirrhosis;
  2. Concurrent AIDS-related or non-related tumors;
  3. Women who are pregnant or breastfeeding;
  4. Presence of serious underlying diseases such as heart, lung, liver, kidney, etc.;
  5. Alcohol abuse or drug use;
  6. The researcher believes that the overall condition of the subject affects the evaluation and completion of the trial
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Obstructive Ventilatory Dysfunction

    FEV1(Forced Expiratory Volume in One Second )to FVC (Forced Vital Capacity ) Ratio

    Time frame: 12 weeks

Secondary outcomes

  1. FEV1

    FEV1 decrease of ≥100 mL

    Time frame: 12 weeks

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Study locations

1 of 1 sites recruiting
  • Guangzhou Eighth People's Hospital, Guangzhou Medical University
    Guangzhou, Guangdong 510060, China
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06137196
Lead sponsor
Guangzhou 8th People's Hospital
Responsible party
Linghua LI (Chief physician, Guangzhou 8th People's Hospital) — Principal investigator
First posted
Nov 18, 2023
Start date
Nov 1, 2023
Primary completion
Nov 1, 2026 (estimated)
Completion
Nov 1, 2027 (estimated)
Last update
Nov 18, 2023

Study contacts

Linghua Li, PhD
Contact
llheliza@126.com
+862083710825
Yaozu He, MD
Contact
hyzdyl99@163.com
15626444697

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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