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NCT Number: NCT06137196

Risk Identification Factors for Pulmonary 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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Obstructive Ventilatory Dysfunction

    Time frame: 12 weeks

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

Secondary outcomes

  1. FEV1

    Time frame: 12 weeks

    FEV1 decrease of ≥100 mL

Study contacts

Contact information is provided by the study sponsor or research team.

Linghua Li, PhD

CONTACT

[email protected]

+862083710825

Yaozu He, MD

CONTACT

[email protected]

15626444697

Sponsors and collaborators

Lead sponsor

Guangzhou 8th People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Nov 18, 2023
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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