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New treatment option for Immunological Non-Responders in People With HIV
Official title Targeted Therapies for Immunological Non-Responders in People With HIV: A Multicenter Clinical Study
ClinicalTrials.gov ID: NCT07637877
What this study is testing
What is cART + Rilpivirine?
cART + Rilpivirine is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for immunological non-responders in people with hiv.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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...
- 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...
- Willing and able to provide written informed consent prior to any study-related procedures, and to comply with all study requirements.
You likely can't join if
- 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 using efavirenz or rilpivirine within 2 years prior to enrollment.
- History of NNRTI resistance.
- Clinical signs suggestive of other serious diseases.
- Long-term use of corticosteroids or other immunosuppressive agents.
See the full eligibility criteria
- 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...
- 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...
- Willing and able to provide written informed consent prior to any study-related procedures, and to comply with all study requirements.
- 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 using efavirenz or rilpivirine within 2 years prior to enrollment.
- History of NNRTI resistance.
- Clinical signs suggestive of other serious diseases.
- Long-term use of corticosteroids or other immunosuppressive agents.
- Co-existing severe AIDS-related or non-AIDS-related events.
- 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...
- 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.
- 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.
- Any other serious condition that may interfere with the conduct of the clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Beijing, China
- Guangzhou, China
- Shenzhen, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Beijing, China; Guangzhou, China; Shenzhen, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.