NCT07637877RecruitingPhase 2
Targeted Therapies for Immunological Non-Responders in People With HIV: A Multicenter Clinical Study
Source: ClinicalTrials.gov · Last updated 24 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 21 (estimated)
- First submitted
- 1 Jun 2026
- Start date
- 15 Jun 2026
- Primary completion date
- 30 Dec 2028
- Lead sponsor
- Beijing 302 Hospital
- Diseases
- HIV
- NCT number
- NCT07637877
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 21
- From 15 Jun 2026 to the primary completion date, 30 Dec 2028
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of using efavirenz or rilpivirine within 2 years prior to enrollment.
- Long-term use of corticosteroids or other immunosuppressive agents.
- Receipt of immunosuppressive or systemic cytotoxic therapy within 6 months prior to screening.
- Evidence of substance abuse within 6 months prior to enrollment, or a positive urine drug screen.
Other illness
- Co-infection with other viruses: positive for any of HBV, HCV, HDV, or HEV; or CMV/EBV viral load \> 1000 copies/mL.
- HIV-2 infection alone or co-infection with HIV-1 and HIV-2.
- History of NNRTI resistance.
- Clinical signs suggestive of other serious diseases.
- Co-existing severe underlying diseases of other systems not related to AIDS.
- 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.
- Any other serious condition that may interfere with the conduct of the clinical trial.
Other
- Co-existing severe AIDS-related or non-AIDS-related events.
- Current participation in another clinical trial that may conflict with the treatment protocol or outcome measures of this study.
- Pregnancy, breastfeeding, or women who have a desire to become pregnant.
- Inability or unwillingness to provide informed consent or comply with study requirements.
Who the study is looking for
- Patients with incomplete immune reconstitution, aged between 18 and 65 years (inclusive).
- 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.
- Within 1 year prior to enrollment, CD4⁺ T cell count remains persistently below 350 cells/μL but above 200 cells/μL.
- 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.
- Willing and able to provide written informed consent prior to any study-related procedures, and to comply with all study requirements.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 302 Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| The Fifth Medical Center of PLA General Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Guangzhou Eighth People's Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| The Third Affiliated Hospital of Sun Yat-Sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Shenzhen Third People's Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.