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Construction of a Clinical Prediction Model for Immune Reconstitution Failure in AIDS Patients: A Prospective Observational Study Based on Machine Learning

Construction of a Clinical Prediction Model for Immune Reconstitution Failure in AIDS Patients: A Prospective Observational Study Based on Machine Learning

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600129502
Enrollment
Unknown
Registered
2026-08-05
Start date
2026-09-01
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Interventions

Observation group:none

Sponsors

Shanghai Public Health Clinical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age >=18 years old; 2. Confirmed HIV infection; 3. Planning to start antiretroviral therapy (ART); 4. Regular follow-up for over 4 years, divided into two groups based on CD4 T cell levels: (1) IR: HIV patients on ART for more than 4 years with CD4 T cell count monitored above 350/µL, defined as good immune reconstitution. They are also further divided into subgroups based on the range of CD4 T cell levels. (2) INR: Patients who have received ART for more than 4 years, with peripheral blood viral load below the detection limit (viral load <50 copies/mL) for over 3 years, but CD4 T cell counts still persistently below 350/µL. 5. Voluntarily participating in this study, able to follow the study protocol to complete all follow-up requirements, and signing the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with combined HBV/HCV infection; 2. Those already diagnosed with other types of immune deficiencies; 3. Patients who have received immunosuppressive or immunomodulatory treatment within the past 6 months before screening; 4. Those with opportunistic infections or AIDS-related malignancies; 5. Pregnant or breastfeeding women; 6. Other patients already diagnosed with serious gastrointestinal, cardiovascular, or cerebrovascular diseases.

Design outcomes

Primary

MeasureTime frame
Construction of a Clinical Prediction Model for Immune Reconstitution Failure in AIDS Patients;

Secondary

MeasureTime frame
Temporal changes in immune function;

Countries

China

Contacts

Public ContactTang Jia

Shanghai Public Health Clinical Center

tangsweetness@163.com+86 21 3799 0333

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 25, 2026