A Multicenter Prospective Clinical Cohort Study on the Pathogen Spectrum of HIV/AIDS Complicated With Infection

NCT ID: NCT06280001

Last Updated: 2024-03-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-31
• Study Completion Date: 2026-11-30

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.

Conditions

Acquired Immunodeficiency Syndrome; HIV Infections

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Ditan Hospital

OTHER

Sponsor Role: collaborator

Beijing YouAn Hospital

OTHER

Sponsor Role: collaborator

Huashan Hospital

OTHER

Sponsor Role: collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role: collaborator

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Jiajia Chen

Chief Physician of the First Affiliated Hospital,Zhejiang University School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiajia Chen

Role: PRINCIPAL_INVESTIGATOR

Zhejiang University

Central Contacts

Jiajia Chen

Role: CONTACT

Jiajiatale0@zju.edu.cn

+8615967109232

Other Identifiers

2023YFC2308802-04

Identifier Type: -

Identifier Source: org_study_id