NCT07637877 Targeted Therapies for Immunological Non-Responders in People With HIV: A Multicenter Clinical Study
| NCT ID | NCT07637877 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Beijing 302 Hospital |
| Condition | Immunological Non-Responders in People With HIV |
| Study Type | INTERVENTIONAL |
| Enrollment | 21 participants |
| Start Date | 2026-06-15 |
| Primary Completion | 2028-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 21 participants in total. It began in 2026-06-15 with a primary completion date of 2028-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Patients with incomplete immune reconstitution, aged between 18 and 65 years (inclusive). 2. At enrollment, have received antiretroviral therapy (ART) for more than 4 years, with plasma HIV-RNA below the lower limit of detection (VL \< 50 copies/mL) for more than 3 years, while CD4⁺ T cell count remains persistently below 350 cells/μL. 3. Within 1 year prior to enrollment, CD4⁺ T cell count remains persistently below 350 cells/μL but above 200 cells/μL. 4. Currently receiving a dolutegravir (DTG)-based ART regimen (e.g., DTG plus lamivudine, or the fixed-dose combination DTG/3TC/ABC) for ≥ 1 year, with no relevant drug resistance detected by high-precision resistance testing; no change in the core ART regimen within 1 year prior to enrollment (adjustments of auxiliary medications for side effect management are permitted); and agree to continue the current integrase inhibitor-based regimen for at least 1 year after enrollment. 5. Willing and able to provide written informed consent prior to any study-related procedures, and to comply with all study requirements. Exclusion Criteria: 1. Co-infection with other viruses: positive for any of HBV, HCV, HDV, or HEV; or CMV/EBV viral load \> 1000 copies/mL. 2. HIV-2 infection alone or co-infection with HIV-1 and HIV-2. 3. History of using efavirenz or rilpivirine within 2 years prior to enrollment. 4. History of NNRTI resistance. 5. Clinical signs suggestive of other serious diseases. 6. Long-term use of corticosteroids or other immunosuppressive agents. 7. Co-existing severe AIDS-related or non-AIDS-related events. 8. Co-existing severe underlying diseases of other systems not related to AIDS. 9. Other severe organic diseases or psychiatric disorders, including any uncontrolled clinically significant disease of the urinary, circulatory, respiratory, nervous, psychiatric, digestive, endocrine, immune systems, or malignancy. 10. Receipt of immunosuppressive or systemic cytotoxic therapy within 6 months prior to screening. 11. Evidence of substance abuse within 6 months prior to enrollment, or a positive urine drug screen. 12. Current participation in another clinical trial that may conflict with the treatment protocol or outcome measures of this study. 13. Pregnancy, breastfeeding, or women who have a desire to become pregnant. 14. Inability or unwillingness to provide informed consent or comply with study requirements. 15. Any other serious condition that may interfere with the conduct of the clinical trial.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07637877 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Immunological Non-Responders in People With HIV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07637877 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07637877 currently recruiting?
Yes, NCT07637877 is actively recruiting participants. Contact the research team at xuruonan2004@aliyun.com for enrollment information.
Where is the NCT07637877 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Guangzhou, China, Guangzhou, China and 1 additional location.
Who is sponsoring the NCT07637877 clinical trial?
NCT07637877 is sponsored by Beijing 302 Hospital. The trial plans to enroll 21 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.