Acquired Immunodeficiency SyndromeNCT06280001
A Multicenter Prospective Clinical Cohort Study on the Pathogen Spectrum of HIV/AIDS Complicated With Infection
An observational study of Acquired Immunodeficiency Syndrome and HIV Infections, run by Zhejiang University.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acquired Immunodeficiency Syndrome, HIV Infections
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV/AIDS patients
Who may be able to join
- Sign the informed consent form.
- HIV positive.
- Any gender, age 18 to 70 years old
Who cannot join
- 1.Patients deemed unsuitable by the investigator to participate in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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
- Keywords
- Infection, Pathogen spectrum, Cohort study
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Infections, Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
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.
Measured: 4 weeks
Secondary outcomes (1)
Survival rate
12-week survival in patients with HIV/AIDS co-infection with secondary infections.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study startMar 2024 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Immunodeficiency SyndromeStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Ditan Hospital, Beijing YouAn Hospital, Huashan Hospital, Qilu Hospital of Shandong University
- Responsible party
- Principal investigator, Jiajia Chen, Zhejiang University
- Investigators
- Jiajia Chen, Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280001
- Sponsor's protocol ID
- 2023YFC2308802-04
- Status last verified
- Mar 2024
- First submitted
- 19 Feb 2024
- Last updated
- 4 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Clinical Cohort Study on the Pathogen Spectrum of HIV/AIDS Complicated With Infection
- ClinicalTrials.gov ID
- NCT06280001
- Acronym / sponsor ID
- 2023YFC2308802-04
- Conditions
- Acquired Immunodeficiency Syndrome, HIV Infections
- Keywords
- Infection, Pathogen spectrum, Cohort study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Beijing Ditan Hospital, Beijing YouAn Hospital, Huashan Hospital, Qilu Hospital of Shandong University
- Study start
- Mar 2024 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV/AIDS patients
Key inclusion criteria (3 listed)
- Sign the informed consent form.
- HIV positive.
- Any gender, age 18 to 70 years old
Key exclusion criteria (1 listed)
- 1.Patients deemed unsuitable by the investigator to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Secondary infections in patients with HIV/AIDS at 4 weeks
Time frame: 4 weeks
Site of infection, pathogen results such as blood or body fluid pathogen cultures or Next-generation sequencing(NGS) results.
quick SEPSIS RELATED ORGAN FAILURE ASSESSMENT(qSOFA) at 4 weeks
Time frame: 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.
1 secondary outcome
Survival rate
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jiajia Chen principal investigator
Zhejiang University
Questions about this trial
What is this clinical trial studying?
An observational study of Acquired Immunodeficiency Syndrome and HIV Infections, run by Zhejiang University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiajia Chen (+8615967109232, Jiajiatale0@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Secondary infections in patients with HIV/AIDS at 4 weeks (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.