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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06280001
• Other study ID #: 2023YFC2308802-04
• Status: Not yet recruiting
• Start date: March 2024
• Est. completion date: November 2026

Study information

• Verified date: March 2024
• Source: Zhejiang University
• Contact: Jiajia Chen
• Phone: +8615967109232
• Email: Jiajiatale0[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: November 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infections
• Immunologic Deficiency Syndromes
• Infections

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Zhejiang University	Beijing Ditan Hospital, Beijing YouAn Hospital, Huashan Hospital, Qilu Hospital of Shandong University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Secondary infections in patients with HIV/AIDS at 4 weeks	Site of infection, pathogen results such as blood or body fluid pathogen cultures or Next-generation sequencing(NGS) results.	4 weeks
Primary	quick SEPSIS RELATED ORGAN FAILURE ASSESSMENT(qSOFA) at 4 weeks	qSOFA consists of 3 items: altered state of consciousness, systolic blood pressure = 100 mmHg, and respiratory rate = 22 respirations/min. 2 or more items, i.e., a qSOFA score of = 2, are considered to be suspicious for sepsis.Higher qSOFA scores are associated with a higher risk of patient death.	4 weeks
Secondary	Survival rate	12-week survival in patients with HIV/AIDS co-infection with secondary infections.	12 weeks