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Study on the Efficacy and Safety of Immunomodulators Combined with Highly Active Antiretroviral Therapy (HAART) in HIV Patients with Refractory Intracranial Inflammation

Study on the Efficacy and Safety of Immunomodulators Combined with Highly Active Antiretroviral Therapy (HAART) in HIV Patients with Refractory Intracranial Inflammation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125710
Enrollment
Unknown
Registered
2026-05-29
Start date
2026-05-29
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

AIDS

Interventions

Experimental group:HAART + Semaglutide Tablets
Control Group B:HAART + lenalidomide tablets
Control Group A:HAART + Mecobalamin Tablets

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Hospitalized patients aged 18–65 years; 2.Confirmed HIV infection and receiving HAART >= 6 months, with plasma viral load 5/mL, protein > 45 mg/dL, elevated cytokines such as CSF IL-6, or intracranial lesions shown on cranial MRI); 4.Voluntarily signed the informed consent form, and able to comply with regular follow-up, specimen collection, and monitoring of adverse reactions related to treatment; 5.Agree to use effective contraception from 4 weeks before the start of the study to 4 weeks after the end of the study;

Exclusion criteria

Exclusion criteria: 1.Pregnant or lactating women, or individuals planning to become pregnant during the study period; 2.Patients with poor treatment compliance. 3.Received immunosuppressive agents, other immunomodulators, or cytotoxic drugs within 6 months prior to screening. 4.Patients with a history or family history of medullary thyroid carcinoma; diabetic ketoacidosis; a history of or high risk for pancreatitis; severe gastrointestinal diseases; severe underlying cardiovascular, cerebrovascular, hepatic, or renal diseases; myelosuppression with neutrophils < 1000/mm^3 or platelets < 75 000/mm^3; venous or arterial thromboembolism; hypersensitivity to the study drug; or other contraindications to study treatment. 5.Unwilling to sign the informed consent form; 6.Positive etiological test for intracranial infection (e.g., bacteria, fungi, Mycobacterium tuberculosis, etc.). 7.Complicated with other central nervous system diseases (e.g., brain tumor, multiple sclerosis, acute cerebrovascular disease). 8.Use of immunosuppressive agents (e.g., glucocorticoids), other immunomodulators (e.g., interferon, thymosin), or cytotoxic drugs within 6 months prior to screening; 9.Planned use of anti-inflammatory agents other than antifungals and antivirals (e.g., nonsteroidal anti-inflammatory drugs) during the study.

Design outcomes

Primary

MeasureTime frame
The efficacy of intracranial inflammation control in patients with HIV complicated with refractory intracranial inflammation;

Secondary

MeasureTime frame
Reduction and disappearance of HIV reservoir, and improvement of microecology;

Countries

China

Contacts

Public ContactZhu Biao

The First Affiliated Hospital, Zhejiang University School of Medicine

1781741486@qq.com+86 571 87236416

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026