NCT06902038

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Jun Chen, MD · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• HIV-1 Infection

Interventions

Type	Name	Description
DRUG	PD-1 inhibitor	100mg of sindilizumab, was dissolved into 50ml of normal saline q3w ×2
DRUG	Sidarbenamide	Sidarbenamide 10mg biw orally for 2 weeks
DRUG	Saline (NaCl 0,9 %) (placebo)	Saline 50ml Q3W ×2

Timeline

• Start date: 2025-03-22
• Primary completion: 2025-12-01
• Completion: 2027-12-31
• First posted: 2025-03-30
• Last updated: 2025-03-30