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Mechanisms of Incomplete Immune Reconstitution in HIV Infection

Mechanisms of Incomplete Immune Reconstitution in HIV Infection

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500114285
Enrollment
Unknown
Registered
2025-12-10
Start date
2024-12-12
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

HIV infection

Interventions

HIV-1 infected immunological responders (IRs):None
healthy controls (HCs):None
HIV-1 infected immunological non-responders (INRs):None

Sponsors

First Affiliated Hospital of Kunming Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Males and females, age between 18 and 50 years, with a male-to-female ratio of approximately 1:1. 2. The time interval between the initial initiation of ART and the last follow-up for enrolled patients did not exceed 8 years. 3. Patients with confirmed HIV-1 infection; 4. A duration of ART treatment of no less than two years was required, with closely matched durations of both HIV infection and ART experience across the enrolled patient cohort; 5. An undetectable viral load was maintained for more than two consecutive years, with no viral rebound during this period; 6. Informed consent was obtained from all patients or their relatives prior to the enrollment in this study; 7. The antiretroviral therapy comprised either TDF + 3TC + EFV or AZT + 3TC + NVP; 8. Patients with complete immune reconstitution (IRs): peripheral blood CD4+ T-cell count > 500 cells/µL. Patients with incomplete immune reconstitution (INRs): peripheral blood CD4+ T-cell count 500/µ l, HIV-1 and HIV-2 antibody testing negative (not infected). 3. Not participating in other clinical trials.

Exclusion criteria

Exclusion criteria: 1. Patient ages below 18 years or above 50 years; 2. Infected by pathogens such as hepatitis viruses, syphilis, sexually transmitted diseases, or herpes simplex virus that have not been cured; 3. Tuberculosis infection; 4. Patients with severe hepatic, renal, cardiac, or cerebral dysfunction, or serious complications such as hypertension, diabetes mellitus, or coronary heart disease; those with severe acute infections that are uncontrolled, or those with suppurative and chronic infections, or non-healing wounds; those with uncontrolled central nervous system metastatic tumors, presenting with significant symptoms of intracranial hypertension or neuropsychiatric symptoms; 5. Poor adherence to ART.

Design outcomes

Primary

MeasureTime frame
Detection of proliferation, activation, cell cycle, and apoptosis in co-cultured CD4+ T cells;Atlas of immune cell clusters from single-cell RNA sequencing;The quantity and function of primary MAIT cells;Clonotypes specific to the INRs and IRs groups in T- and B-cell immune repertoires;Expression levels of CAR molecules on MAIT cells;Analyses of cell cycle and apoptosis in naive B cells (CFSE/PI staining);Measurement of secreted IgG antibody levels (IgG1, IgG2, IgG3, IgG4);Cytotoxic activity against HIV-1 latent target cells (CD4+ T, ACH2 cells) by CAR-MAIT cells;

Secondary

MeasureTime frame
The inflammatory cytokine expression (IL-2, IFN-?, TNF-a, GZMB, GM-CSF) in CAR-MAIT cells;Levels of pro-inflammatory and anti-inflammatory cytokines in peripheral blood samples;The number and proportions of naive B cells;Expression of phenotypic markers on CD4+, CD8+ T cells, including apoptosis marker (CD95), activation markers (CD38, HLA-DR, Ki67), immunosenescence marker (CD57), exhaustion marker(CD279);Detection of immunophenotypic markers on naive B cells;The secretion of inflammatory factors (IL-2, IL-4, IL-17, IFN-?, TNF-a) by co-cultured CD4+ T cells;

Countries

China

Contacts

Public ContactYiqun Kuang

First Affiliated Hospital of Kunming Medical University

yq610433@hotmail.com+86 871 6532 4888

Outcome results

None listed

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