Acquired Immune Deficiency Syndrome
Conditions
Interventions
High-dose group:Treatment with Epalolizumab and Vorinostat Injection (2 mg/kg per administration, every 4 weeks +/- 1 day, for a total of 3 doses) in combination with C
Low-dose group:Treatment with Epalolizumab and Vorinostat Injection (0.3 mg/kg per administration, every 4 weeks +/- 1 day, for a total of 3 doses) in combination with
Medium-dose group:Treatment with Epalolizumab and Vorinostat Injection (1 mg/kg per administration, every 4 weeks +/- 1 day, for a total of 3 doses) in combination with C
Sponsors
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18–65 years. 2. Confirmed HIV infection by both initial screening assay and Western blot (WB) confirmatory test. 3. Receiving a stable ART regimen for at least 6 months. 4. Viral load below the lower limit of detection. 5. CD4+ T-cell count >200 cells/mm³. 6. Voluntarily signed the informed consent form and able to comply with regular follow-up visits, specimen collection, and monitoring/treatment of study-related adverse events. 7. Use effective contraception from 4 weeks prior to study initiation until 4 weeks after study completion.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women, or women planning to become pregnant during the study observation period. 2. Subjects with poor treatment adherence. 3. Receipt of immunosuppressants, other immunomodulatory agents, or cytotoxic drugs within 6 months prior to screening. 4. Presence of severe underlying cardiac, cerebral, hepatic, renal, or other systemic diseases; neutrophil count <1000/mm³; platelet count <75,000/mm³; allergy to the investigational drug; or other contraindications to treatment. 5. Presence of progressive (or active) malignancy, including but not limited to advanced, metastatic, or unresectable solid tumors or hematologic malignancies. 6. Unwillingness to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of the combination therapy of Epalolizumab and Vorinostat Injection with Chidamide.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the HIV reservoir; | — |
Countries
China
Contacts
Public ContactBiao Zhu
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed