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Targeted Therapies for Immunological Non-Responders in People With HIV: A Multicenter Clinical Study
Sponsor: Beijing 302 Hospital
Summary
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.
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
21
Start Date
2026-06-15
Completion Date
2029-01-30
Last Updated
2026-09-24
Healthy Volunteers
No
Interventions
cART + Rilpivirine
Participants receive standard combination antiretroviral therapy (cART) plus rilpivirine
cART
Participants receive standard combination antiretroviral therapy (cART) alone
Locations (5)
The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, China
302 Hospital
Beijing, China
Guangzhou Eighth People's Hospital
Guangzhou, China
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, China
Shenzhen Third People's Hospital
Shenzhen, China