Clinical Research on the Use of Immune Checkpoint Inhibitors Combined With Chidamide for the Functional Cure of AIDS

NCT06902038 | Not Yet Recruiting

• 1 other identifier: PD-1 inhibitor
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

Brief Summary

Evaluate the efficacy and safety of immune checkpoint inhibitors combined with chidamide as an "activate and kill" strategy to extend viral rebound time, reduce the HIV reservoir, and achieve functional cure.

Conditions

HIV-1 Infection

Outcome Measures

Primary Outcomes (1)

• Time interval from antiretroviral therapy interruption to antiretroviral treatment restart

  From baseline to the date of antiretroviral treatment restart, up to 12 weeks

Secondary Outcomes (5)

• The ratio of HIV RNA<50 copies /ml was maintained at 12 weeks

  12 weeks

• Changes in HIV DNA levels from baseline to antiretroviral treatment restart

  From baseline to the date of antiretroviral treatment restart, up to 12 weeks

• Incidence of drug-related adverse events before antiretroviral treatment restart

  From date of randomization to the date of antiretroviral treatment restart, up to 14 weeks.

• Changes in HIV-specific CD8+ T response from baseline with Day8 and Day29 and ART restart

  From baseline to Day 8, Day 29 and antiretroviral treatment restart, up to 12 weeks

• Changes in PD-1 (+) CD4 T cells and CD8 T cells from baseline at Day8 and Day29 and ART restart

  From baseline to Day 8, Day 29 and antiretroviral treatment restart, up to 12 weeks

Study Arms (3)

Control group

PLACEBO COMPARATOR

Saline 50ml q3w ×2

Drug: Saline (NaCl 0,9 %) (placebo)

Experimental sindilizumab

EXPERIMENTAL

100mg of sindilizumab, was dissolved in 50ml normal saline, q3w was administered ×2

Drug: PD-1 inhibitor

Experimental sindilizumab and sidarbenamide

EXPERIMENTAL

100mg of sindilizumab, was dissolved into 50ml of normal saline q3w ×2+ sidarbenamide 10mg biw orally for 2 weeks

Drug: PD-1 inhibitor; Drug: Sidarbenamide

Interventions

PD-1 inhibitor DRUG

100mg of sindilizumab, was dissolved into 50ml of normal saline q3w ×2

Experimental sindilizumab; Experimental sindilizumab and sidarbenamide

Sidarbenamide DRUG

Sidarbenamide 10mg biw orally for 2 weeks

Experimental sindilizumab and sidarbenamide

Saline (NaCl 0,9 %) (placebo) DRUG

Saline 50ml Q3W ×2

Also known as: Placebo Comparator

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People diagnosed with HIV infection;
• Age ≥18 years old;
• General good health, body mass index ≥18.0 to \<35.0 kg/m2;
• Able and willing to comply with the time requirements for research visits and evaluations;
• have received ART therapy for at least 24 months, and plasma HIV-1 RNA \< 50 copies /ml for two consecutive times with a time interval of at least 12 months;
• During the screening period, the number of CD4+ T cells was ≥350 cells /μl(including boundary values);
• Agree to adhere to contraception during the course of participating in the project and within 6 months after the end of the trial;
• Willing to sign informed consent

You may not qualify if:

• Have suffered from any serious acute disease within 8 weeks;
• Subjects with a history of active autoimmune disease or autoimmune disease requiring systemic treatment;
• Pre-treatment/exposure to any other immune checkpoint inhibitor \[e.g., anti-programmed cell death protein 1(PD-1), anti-PD-L1, anti-PD-L2, anti-CTLA4, etc.\].
• The patient has received the following treatment:
• Received other anti-latency drugs within 30 days prior to enrollment;
• Radiotherapy or chemotherapy 30 days before screening;
• Immunosuppressive therapy 60 days before screening;
• Treatment with immunomodulators (e.g., interleukin, interferon), hydroxyurea, or phosphonic acid 60 days prior to screening
• Receiving HIV vaccine or systemic cytotoxic chemotherapy 60 days before screening;
• Previous immunoglobulin (IgG) therapy
• Received blood transfusion or cell growth factor therapy in the 90 days prior to screening
• Drugs such as rifampicin and rifambutin were being used at the time of screening or at the planned treatment stage;
• Laboratory tests meet the following standards:
• Absolute neutrophil count (ANC) \< 1.50×109/L; Hemoglobin (Hb) \< 105g/L(male) or \< 95g/L(female); Platelet \< 75×109/μL; International Normalized Ratio (INR) \> 1× Upper Limit of Normal (ULN)
• Serum alanine aminotransferase (ALT) \> 1.5× upper limit of normal (ULN), serum aspartate aminotransferase (SGOT/AST) \> 1.5× upper limit of normal (ULN), total bilirubin, direct bilirubin \> 1.5× upper limit of normal (ULN), serum creatinine \> 1.5× upper limit of normal (ULN), And the abnormality has clinical significance;

Sponsors & Collaborators

• Jun Chen, MD: lead

MeSH Terms

Interventions

Immune Checkpoint Inhibitors; Sodium Chloride

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Jun Chen, MD

  Shanghai Public Health Clinical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Chen, MD

CONTACT

021-37990333; qtchenjun@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Director of Infection and Immunization

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 30, 2025
• Study Start: March 22, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 30, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share