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A Study on the Detailed Landscape of Immune Cell Subsets and Related Mechanisms in Different Immune Reconstitution States After ART Treatment in HIV-Infected Individuals

A Study on the Detailed Landscape of Immune Cell Subsets and Related Mechanisms in Different Immune Reconstitution States After ART Treatment in HIV-Infected Individuals

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600118591
Enrollment
Unknown
Registered
2026-02-09
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-02-16

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

Case group:None
Control group:None

Sponsors

The First Affiliated Hospital, College of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Inclusion criteria for the case group: (1) Age 18 to 65 years (inclusive); (2) Confirmed HIV infection by initial screening and Western Blot confirmatory testing; (3) On ART for at least 1 year, with an integrase inhibitor-based ART regimen used in the past 3 months; (4) Viral load below the lower limit of detection (20 COPIES/ML); (5) CD4+ T-cell count > 200 cells/MM3 within the past 6 months; (6) Voluntarily signed informed consent and able to comply with sample collection and potential adverse reactions; (7) Undergoing monitoring from 4 weeks before study initiation to 4 weeks after study completion. 2. Inclusion criteria for healthy controls: (1) Age 18 to 65 years (inclusive); (2) Negative for four infectious disease screenings and no autoimmune-related diseases; (3) No underlying cardiovascular, respiratory, renal, hepatic, or cerebral diseases or other health conditions that may affect study outcomes; (4) No severe psychiatric disorders; (5) No solid or hematologic malignancies; (6) No active opportunistic infections; (7) Non-pregnant and non-lactating women. Use of contraceptive measures.

Exclusion criteria

Exclusion criteria: Case group: 1. Pregnant or lactating women, or those planning pregnancy during the study period; 2. Suffering from severe cardiovascular, respiratory, renal, hepatic, or cerebral underlying diseases; 3. Suffering from severe psychiatric disorders; 4. Coexisting solid or hematologic malignancies; 5. Coexisting active opportunistic infections; 6. Unwilling to sign the informed consent form; 7. Other conditions deemed unsuitable for participation in this study by the investigator.

Design outcomes

Primary

MeasureTime frame
CD4+ T cell count;HIV-1 RNA viral load;Peripheral blood mononuclear cell subset distribution;Serum biomarker levels;Gut and oral microbiota composition;

Countries

China

Contacts

Public ContactZhang Yimin

The First Affiliated Hospital, College of Medicine, Zhejiang University

1307020@zju.edu.cn+86 135 8818 0966

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026