Clinical trial NCT06280001: A Multicenter Prospective Clinical Cohort Study on the Pathogen Spectrum of HIV/AIDS Complicated With Infection
Official title: A Multicenter Prospective Clinical Cohort Study on the Pathogen Spectrum of HIV/AIDS Complicated With Infection
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acquired Immunodeficiency Syndrome
HIV Infections
Keywords: Infection
Pathogen spectrum
Cohort study
Lead sponsor: Zhejiang University
Sponsor class: OTHER
Collaborators: name: Beijing Ditan Hospital
name: Beijing YouAn Hospital
name: Huashan Hospital
name: Qilu Hospital of Shandong University
First posted: 2024-02-28
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV/AIDS patients

Brief summary: The goal of this observational study is to determine the incidence and spectrum of opportunistic infections among Chinese HIV/AIDS patients at this stage, to find intervention targets, to construct an early warning prediction model, and to give an individualized program with integrated immune function to obtain salvage opportunities for patients.The main questions it aims to answer are:

* Describe the populations and characteristics of pathogenic microorganisms involved in HIV co-infection, map the spatial and temporal changes in the infection system of pathogenic microorganisms, and evaluate their impact on disease regression.
* Explore the mechanism of interaction between pathogenic microorganisms and host autoimmune deficiencies.
* Discover early warning and predictive markers and immunological indicators of pathogenic microorganisms, and explore new technologies and programs to reduce the mortality rate of infection.

Detailed description: AIDS is a chronic systemic disease caused by human immunodeficiency virus (HIV), which leads to reduced or defective immune function, causing a variety of serious opportunistic infections and tumors, and a significant increase in the mortality rate. This study focuses on the impact of secondary infections on the clinical prognosis of patients with HIV/AIDS, and intends to establish a prospective, multicenter clinical cohort of HIV/AIDS patients with combined infections with a variety of pathogens, to map the infectious pathogens, to correlate the characteristics of the basic immune status with the spectrum of pathogens of secondary infections, and to establish a monitoring and early-warning system of secondary infections, so that we can explore safe and effective treatments to further reduce the disease and mortality rate.

Eligibility criteria: Inclusion Criteria:

1. Sign the informed consent form.
2. HIV positive.
3. Any gender, age 18 to 70 years old

Exclusion Criteria:

1.Patients deemed unsuitable by the investigator to participate in the study.

Primary outcomes:
measure: Secondary infections in patients with HIV/AIDS at 4 weeks
timeFrame: 4 weeks
measure: quick SEPSIS RELATED ORGAN FAILURE ASSESSMENT(qSOFA) at 4 weeks
timeFrame: 4 weeks
Secondary outcomes:
measure: Survival rate
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Zhejiang University
name: Jiajia Chen
role: PRINCIPAL_INVESTIGATOR
References: