HIV-1 InfectionNCT06902038
Clinical Research on the Use of Immune Checkpoint Inhibitors Combined With Chidamide for the Functional Cure of AIDS
A study testing PD-1 inhibitor and Sidarbenamide in people with HIV-1 Infection, run by Jun Chen, MD.
Trial summary
Evaluate the efficacy and safety of immune checkpoint inhibitors combined with chidamide as an "activate and kill" strategy to extend viral rebound time, reduce the HIV reservoir, and achieve functional cure. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV-1 Infection
- What is being tested?
- PD-1 inhibitor and Sidarbenamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 22 Mar 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- People diagnosed with HIV infection;
- Age ≥18 years old;
- General good health, body mass index ≥18.0 to <35.0 kg/m2;
- Able and willing to comply with the time requirements for research visits and evaluations;
- have received ART therapy for at least 24 months, and plasma HIV-1 RNA < 50 copies /ml for two consecutive times with a time interval of at least 12 months;
- During the screening period, the number of CD4+ T cells was ≥350 cells /μl(including boundary values);
- Agree to adhere to contraception during the course of participating in the project and within 6 months after the end of the trial;
- Willing to sign informed consent
Who cannot join
- Have suffered from any serious acute disease within 8 weeks;
- Subjects with a history of active autoimmune disease or autoimmune disease requiring systemic treatment;
- Pre-treatment/exposure to any other immune checkpoint inhibitor [e.g., anti-programmed cell death protein 1(PD-1), anti-PD-L1, anti-PD-L2, anti-CTLA4, etc.].
- The patient has received the following treatment:
- Received other anti-latency drugs within 30 days prior to enrollment;
- Radiotherapy or chemotherapy 30 days before screening;
Show all 34Show fewer
- Immunosuppressive therapy 60 days before screening;
- Treatment with immunomodulators (e.g., interleukin, interferon), hydroxyurea, or phosphonic acid 60 days prior to screening
- Receiving HIV vaccine or systemic cytotoxic chemotherapy 60 days before screening;
- Previous immunoglobulin (IgG) therapy
- Received blood transfusion or cell growth factor therapy in the 90 days prior to screening
- Drugs such as rifampicin and rifambutin were being used at the time of screening or at the planned treatment stage;
- Laboratory tests meet the following standards:
- Absolute neutrophil count (ANC) < 1.50×109/L; Hemoglobin (Hb) < 105g/L(male) or < 95g/L(female); Platelet < 75×109/μL; International Normalized Ratio (INR) > 1× Upper Limit of Normal (ULN)
- Serum alanine aminotransferase (ALT) > 1.5× upper limit of normal (ULN), serum aspartate aminotransferase (SGOT/AST) > 1.5× upper limit of normal (ULN), total bilirubin, direct bilirubin > 1.5× upper limit of normal (ULN), serum creatinine > 1.5× upper limit of normal (ULN), And the abnormality has clinical significance;
- Five abnormalities of thyroid function with clinical significance: test items include triiodothyronine (T3), tetraiodothyronine (T4), free triiodothyronine (FT3), free tetraiodothyronine (FT4), and thyroid stimulating hormone (TSH).
- The epinephrine test was abnormal and clinically significant;
- Blood glucose and glycated hemoglobin were abnormal and clinically significant
- Twelve-lead electrocardiogram was abnormal and clinically significant at the time of enrollment;
- Interstitial changes were detected by chest CT at the time of enrollment;
- Subjects with severe heart disease, symptomatic or asymptomatic arrhythmia;
- Patients with co-infection such as HBV, HCV, syphilis, diabetes, and other liver diseases;
- Subjects with a history of active or suspected malignancy or malignancy (other than basal cell skin cancer or cervical cancer in situ) within five years.
- Subjects with a history of tuberculosis or active tuberculosis.
- Subjects with psychiatric or substance abuse disorders known to interfere with the requirements of the experiment.
- Subjects who received immunomodulatory or immunosuppressive therapy in the 24 weeks prior to first taking the study drug.
- Pregnant and lactating women;
- Mental illness or drug abuse interferes with the conduct of the test.
- Histone deacetylase inhibitors, such as valproic acid, butyrate, phenyl butyrate, etc., but can be included after a 28-day washout period;
- Patients with severe cardiac insufficiency [New York College of Cardiology (NYHA) Grade IV for cardiac insufficiency];
- any arterial thromboembolism event, including myocardial infarction, unstable angina pectoris, cerebrovascular accident, or transient ischemic attack, occurred within 6 months prior to treatment induction; Standardized treatment of uncontrolled hypertension (systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg); Cardiomyopathy;
- Patients had significant QT/QTC intervals during the screening period (Fridericia formula: QTcF=QT/RR0.33) prolonged (e.g., repeated measurements show a QTc interval >450 ms, or there is another risk of torsive ventricular TdP [e.g., heart failure, hypokalemia, familial long QT syndrome]) or combined use of drugs that may cause a prolonged QT/QTc interval;
- Allergic or anti-drug antibodies to the drug or excipient used in this test are known.
- The researchers judged that they were not suitable to participate in this experiment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Evaluate the efficacy and safety of immune checkpoint inhibitors combined with chidamide as an "activate and kill" strategy to extend viral rebound time, reduce the HIV reservoir, and achieve functional cure.
Read the detailed description
This project plans to conduct a prospective randomized controlled study, using immune checkpoint inhibitors combined with chidamide, while applying antiretroviral therapy interruption(ATI) to further enhance the immune killing effect of this strategy, with the aim of accelerating the clearance of the HIV reservoir and delaying the time of viral rebound, thereby achieving a functional cure for AIDS.
- Conditions
- HIV-1 Infection
- Being tested
- PD-1 inhibitor, Sidarbenamide, Saline (NaCl 0,9 %) (placebo)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 inhibitorDrug
100mg of sindilizumab, was dissolved into 50ml of normal saline q3w ×2
SidarbenamideDrug
Sidarbenamide 10mg biw orally for 2 weeks
Saline (NaCl 0,9 %) (placebo)Drug
Also called Placebo Comparator
Saline 50ml Q3W ×2
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Saline 50ml q3w ×2 Receives: Drug: Saline (NaCl 0,9 %) (placebo) |
| Experimental sindilizumab | Experimental | 100mg of sindilizumab, was dissolved in 50ml normal saline, q3w was administered ×2 Receives: Drug: PD-1 inhibitor |
| Experimental sindilizumab and sidarbenamide | Experimental | 100mg of sindilizumab, was dissolved into 50ml of normal saline q3w ×2+ sidarbenamide 10mg biw orally for 2 weeks Receives: Drug: PD-1 inhibitor; Drug: Sidarbenamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time interval from antiretroviral therapy interruption to antiretroviral treatment restart
Measured: From baseline to the date of antiretroviral treatment restart, up to 12 weeks
Secondary outcomes (5)
The ratio of HIV RNA<50 copies /ml was maintained at 12 weeks
Measured: 12 weeks
Changes in HIV DNA levels from baseline to antiretroviral treatment restart
Measured: From baseline to the date of antiretroviral treatment restart, up to 12 weeks
Incidence of drug-related adverse events before antiretroviral treatment restart
Measured: From date of randomization to the date of antiretroviral treatment restart, up to 14 weeks.
Changes in HIV-specific CD8+ T response from baseline with Day8 and Day29 and ART restart
Measured: From baseline to Day 8, Day 29 and antiretroviral treatment restart, up to 12 weeks
Changes in PD-1 (+) CD4 T cells and CD8 T cells from baseline at Day8 and Day29 and ART restart
Measured: From baseline to Day 8, Day 29 and antiretroviral treatment restart, up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start22 Mar 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jun Chen, MD
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Jun Chen, MD, Shanghai Public Health Clinical Center
- Investigators
- Jun Chen, MD, Principal investigator, Shanghai Public Health Clinical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06902038
- Sponsor's protocol ID
- PD-1 inhibitor
- Status last verified
- Feb 2025
- First submitted
- 25 Feb 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research on the Use of Immune Checkpoint Inhibitors Combined With Chidamide for the Functional Cure of AIDS
- ClinicalTrials.gov ID
- NCT06902038
- Acronym / sponsor ID
- PD-1 inhibitor
- Conditions
- HIV-1 Infection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Jun Chen, MDOther government
- Study start
- 22 Mar 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the efficacy and safety of immune checkpoint inhibitors combined with chidamide as an "activate and kill" strategy to extend viral rebound time, reduce the HIV reservoir, and achieve functional cure.
Detailed description
This project plans to conduct a prospective randomized controlled study, using immune checkpoint inhibitors combined with chidamide, while applying antiretroviral therapy interruption(ATI) to further enhance the immune killing effect of this strategy, with the aim of accelerating the clearance of the HIV reservoir and delaying the time of viral rebound, thereby achieving a functional cure for AIDS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: Saline (NaCl 0,9 %) (placebo)Saline 50ml q3w ×2 |
| Experimental sindilizumab | Experimental | Drug: PD-1 inhibitor100mg of sindilizumab, was dissolved in 50ml normal saline, q3w was administered ×2 |
| Experimental sindilizumab and sidarbenamide | Experimental | Drug: PD-1 inhibitor, Drug: Sidarbenamide100mg of sindilizumab, was dissolved into 50ml of normal saline q3w ×2+ sidarbenamide 10mg biw orally for 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- People diagnosed with HIV infection;
- Age ≥18 years old;
- General good health, body mass index ≥18.0 to <35.0 kg/m2;
- Able and willing to comply with the time requirements for research visits and evaluations;
- have received ART therapy for at least 24 months, and plasma HIV-1 RNA < 50 copies /ml for two consecutive times with a time interval of at least 12 months;
Key exclusion criteria (34 listed)
- Have suffered from any serious acute disease within 8 weeks;
- Subjects with a history of active autoimmune disease or autoimmune disease requiring systemic treatment;
- Pre-treatment/exposure to any other immune checkpoint inhibitor [e.g., anti-programmed cell death protein 1(PD-1), anti-PD-L1, anti-PD-L2, anti-CTLA4, etc.].
- The patient has received the following treatment:
- Laboratory tests meet the following standards:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PD-1 inhibitor100mg of sindilizumab, was dissolved into 50ml of normal saline q3w ×2 | Drug | Experimental sindilizumab, Experimental sindilizumab and sidarbenamide |
| SidarbenamideSidarbenamide 10mg biw orally for 2 weeks | Drug | Experimental sindilizumab and sidarbenamide |
| Saline (NaCl 0,9 %) (placebo)Also: Placebo ComparatorSaline 50ml Q3W ×2 | Drug | Control group |
Primary outcome
Time interval from antiretroviral therapy interruption to antiretroviral treatment restart
Time frame: From baseline to the date of antiretroviral treatment restart, up to 12 weeks
5 secondary outcomes
The ratio of HIV RNA<50 copies /ml was maintained at 12 weeks
Time frame: 12 weeks
Changes in HIV DNA levels from baseline to antiretroviral treatment restart
Time frame: From baseline to the date of antiretroviral treatment restart, up to 12 weeks
Incidence of drug-related adverse events before antiretroviral treatment restart
Time frame: From date of randomization to the date of antiretroviral treatment restart, up to 14 weeks.
Changes in HIV-specific CD8+ T response from baseline with Day8 and Day29 and ART restart
Time frame: From baseline to Day 8, Day 29 and antiretroviral treatment restart, up to 12 weeks
Changes in PD-1 (+) CD4 T cells and CD8 T cells from baseline at Day8 and Day29 and ART restart
Time frame: From baseline to Day 8, Day 29 and antiretroviral treatment restart, up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for HIV-1 Infection
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
HIV-1-infection
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jun Chen, MD principal investigator
Shanghai Public Health Clinical Center
Questions about this trial
What is this clinical trial studying?
A study testing PD-1 inhibitor and Sidarbenamide in people with HIV-1 Infection, run by Jun Chen, MD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Chen, MD (021-37990333, qtchenjun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time interval from antiretroviral therapy interruption to antiretroviral treatment restart (time frame: From baseline to the date of antiretroviral treatment restart, up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.