Targeted Therapies for Immunological Non-Responders in People With HIV: A Multicenter Clinical Study

This study focuses on people with HIV who experience incomplete immune reconstitution despite suppressive antiretroviral therapy (ART), characterized by persistently low CD4⁺ T cell counts and residual inflammation. The underlying cause is largely attributed to the persistent HIV latent reservoir. Recent evidence indicates that rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) commonly used in ART, has an immunomodulatory function beyond its antiviral activity. It activates the CARD8 inflammasome - an intracellular "kill switch" - triggering pyroptosis selectively in HIV-infected cells. In this study, rilpivirine will be added to suppressive ART in patients with incomplete immune reconstitution. The investigators hypothesize that this strategy will reduce the latent reservoir, restore CD4⁺ T cell counts and function, attenuate excessive immune activation, and ultimately improve long-term clinical outcomes.

NCT Number	NCT07637877
Lead Sponsor	Beijing 302 Hospital Collaborators: Shenzhen Third People's Hospital, Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou Eighth People's Hospital
Conditions	Immunological Non-Responders in People With HIV
Enrollment	21 participants
Start Date	2026-06-15
Primary Completion	2028-12-30 (estimated)
Study Completion	2029-01-30 (estimated)
Updated on ClinicalTrials.gov	2026-07-13