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

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

NCT06902038•Jun Chen, MD

View on ClinicalTrials.gov

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.

Detailed Description

This project plans to conduct a prospective randomized controlled study, using immune checkpoint inhibitors combined with chidamide, while applying antiretroviral therapy interruption(ATI) to further enhance the immune killing effect of this strategy, with the aim of accelerating the clearance of the HIV reservoir and delaying the time of viral rebound, thereby achieving a functional cure for AIDS.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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

Exclusion Criteria

•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:
•1. Received other anti-latency drugs within 30 days prior to enrollment;
•2. Radiotherapy or chemotherapy 30 days before screening;
•3. Immunosuppressive therapy 60 days before screening;
•4. Treatment with immunomodulators (e.g., interleukin, interferon), hydroxyurea, or phosphonic acid 60 days prior to screening
•5. Receiving HIV vaccine or systemic cytotoxic chemotherapy 60 days before screening;
•6. Previous immunoglobulin (IgG) therapy
+24 more criteria

Key Dates

Start Date

March 22, 2025

Primary Completion Date

December 1, 2025

Completion Date

December 31, 2027

Last Updated

March 30, 2025

Enrollment

ESTIMATED participants

Conditions

HIV-1 Infection

Interventions

PD-1 inhibitor

DRUG

Sidarbenamide

DRUG

Saline (NaCl 0,9 %) (placebo)

DRUG

Contacts

Jun Chen, MD

CONTACT

021-37990333 qtchenjun@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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