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RECRUITING
NCT07637877
PHASE2

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

Sponsor: Beijing 302 Hospital

View on ClinicalTrials.gov

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

DRUG

cART + Rilpivirine

Participants receive standard combination antiretroviral therapy (cART) plus rilpivirine

DRUG

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