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

Study on Risk Identification Factors for Lung Function Impairment in AIDS Patients Recovered From Severe Pneumonia

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06137196

Enrollment

100

Registered

2023-11-18

Start date

2023-11-01

Completion date

2027-11-01

Last updated

2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AIDS, Pneumonia

Keywords

AIDS, Severe pneumonia, Lung function, Predictive factors

Brief 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.

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

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

Design outcomes

Primary

Measure	Time frame	Description
Obstructive Ventilatory Dysfunction	12 weeks	FEV1(Forced Expiratory Volume in One Second )to FVC (Forced Vital Capacity ) Ratio

Secondary

Measure	Time frame	Description
FEV1	12 weeks	FEV1 decrease of ≥100 mL

Countries

China

Contacts

Primary ContactLinghua Li, PhD

llheliza@126.com+862083710825

Backup ContactYaozu He, MD

hyzdyl99@163.com15626444697

Outcome results