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Association of Inflammation-Based Hematologic Indices with Immune Reconstitution in People Living with HIV: Development and Validation of a Predictive Model

Association of Inflammation-Based Hematologic Indices with Immune Reconstitution in People Living with HIV: Development and Validation of a Predictive Model

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500113021
Enrollment
Unknown
Registered
2025-11-24
Start date
2025-12-10
Completion date
Unknown
Last updated
2025-12-01

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

Conditions

Acquired Immune Deficiency Syndrome

Interventions

Observation group:None

Sponsors

Fujian Maternity and Child Health Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Confirmed HIV-1 infection and receipt of guideline-concordant antiretroviral therapy (ART) for >=2 years. 2.Age >=18 years at ART initiation, regardless of sex. 3.Availability of baseline laboratory data within ±14 days of ART initiation, including CD4 count, HIV-1 RNA viral load, complete blood count (CBC), and basic biochemistry. 4.At least two post-ART measurements of CD4 and HIV-1 RNA (preferably at months 6, 12, and 24).

Exclusion criteria

Exclusion criteria: 1.Virologic non-suppression at both 12 and 24 months: HIV-1 RNA not reduced to the assay lower limit of detection (250 IU/mL) at either time point. 2.Evidence at baseline of any of the following extreme laboratory abnormalities: platelet count (PLT) 400 IU/L; or eGFR <15 mL/min/1.73 m². 3.Concurrent missingness of both CD4 and HIV-1 RNA at baseline, 12 months, and 24 months (i.e., CD4 and viral load unavailable at each of these assessment windows).

Design outcomes

Secondary

MeasureTime frame
Biochemical blood routine, liver and kidney function;

Primary

MeasureTime frame
VL, CD4+;

Countries

China

Contacts

Public ContactJinhua Zhang

Fujian Maternity and Child Health Hospital

pollyzhang2006@126.com+86 133 0691 2381

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026