HIVPhase 1/2NCT07579247
Efficacy and Safety of Immune Checkpoint Inhibitors for Refractory Opportunistic Infections in AIDS
A Phase 1/2 study testing Sintilimab in people with HIV and AIDS, run by Shanghai Public Health Clinical Center at 1 site in China.
Trial summary
This prospective, single-arm, open-label study aims to evaluate the efficacy and safety of a PD-1 inhibitor (Sintilimab) combined with standard anti-infective therapy in patients with advanced HIV disease (AHD) who are suffering from refractory opportunistic infections (OIs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, AIDS, Immune Checkpoint Inhibitors
- What is being tested?
- Sintilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- May 2026to Dec 2029
- Phase
- Phase 1/2
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years. Confirmed HIV-1 infection.
- Must have at least one opportunistic infection meeting the "refractory" criteria after currently available standard anti-infective treatment, defined as follows:
- Parvovirus B19: Hemoglobin (Hb) fails to recover (increase <10g/L) or requires transfusion maintenance, with reticulocytes persistently <1% after 4 weeks of Intravenous Immunoglobulin (IVIG) therapy.
- Cytomegalovirus (CMV): Blood/body fluid CMV-DNA decrease <1 log10 or new/worsening organ damage after 2 weeks of Ganciclovir or Foscarnet therapy.
- Mpox virus: Unhealed lesions, new lesions, necrotic coalescence, or no decrease in viral load after 14 days of Tecovirimat, Cidofovir, or Brincidofovir therapy.
- Progressive Multifocal Leukoencephalopathy (PML): Continuous deterioration of neurological symptoms or expanded lesion area on MRI after 3 months of optimized antiretroviral therapy (ART).
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- Pneumocystis jirovecii pneumonia (PCP): No improvement in oxygenation index or expanded radiological lesions after 8 days of adequate SMZ-TMP therapy.
- Cryptococcal meningitis: Persistently positive cerebrospinal fluid (CSF) culture after 4 weeks of induction therapy.
- Talaromyces marneffei / Invasive Aspergillosis: Persistently positive culture or progression of radiological/clinical symptoms after 2 weeks of Amphotericin B or Voriconazole therapy.
- Mycobacterium tuberculosis (TB): Persistently positive sputum smear or culture after 2 months of standard anti-tuberculosis therapy.
- Nontuberculous mycobacteria (NTM): No improvement in clinical symptoms after 1 month of standard therapy, or culture not turning negative after 3 months.
- High PD-1 expression on peripheral CD8+ T cells (>25%) OR weak pathogen-specific ELISpot response (<50 SFCs/10^6 cells).
- Agreement to use highly effective contraception during the study and for 6 months after the end of the trial.
- Voluntary signing of informed consent.
Who cannot join
- History of active autoimmune disease or autoimmune disease requiring systemic treatment.
- Prior organ transplantation or hematopoietic stem cell transplantation. Pregnant or lactating women. Known allergy or anti-drug antibodies to the study drug or its excipients. Prior treatment or exposure to any other immune checkpoint inhibitors. Received immunomodulatory or immunosuppressive therapy (excluding glucocorticoids) within 24 weeks prior to the first dose of the study drug.
- Psychiatric disorders or substance abuse that may interfere with the trial. Other severe medical conditions deemed by the investigator as unsuitable for trial participation (e.g., uncontrolled severe heart, liver, or renal failure).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 201508
Jun Chen, 021-37990333, chenjun@shaphc.org
About this study
Official title: A Study on the Efficacy and Safety of Immune Checkpoint Inhibitors in the Treatment of AIDS Complicated With Refractory Opportunistic Infections
This prospective, single-arm, open-label study aims to evaluate the efficacy and safety of a PD-1 inhibitor (Sintilimab) combined with standard anti-infective therapy in patients with advanced HIV disease (AHD) who are suffering from refractory opportunistic infections (OIs).
Despite effective antiretroviral therapy (ART), some HIV patients develop severe, hard-to-treat infections (such as CMV, PCP, Tuberculosis, etc.) that do not respond to standard antimicrobial treatments. This is often due to a condition called "immune exhaustion," where the body's infection-fighting T-cells become inactive and express high levels of a protein called PD-1.
Sintilimab is an immune checkpoint inhibitor that blocks PD-1, effectively "waking up" the exhausted T-cells. While traditionally used for cancer, recent evidence suggests it can safely restore the immune system's ability to clear stubborn infections in HIV patients. In this study, eligible patients with refractory OIs and evidence of immune exhaustion will receive Sintilimab (200 mg intravenously every 3 weeks for a total of 3 doses) alongside their regular treatments. Researchers will monitor patient safety, clinical improvement, and immunological recovery.
- Being tested
- Sintilimab
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Opportunistic Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
Sintilimab 200 mg dissolved in 100 ml normal saline, administered via intravenous infusion (60 minutes) once every 3 weeks for a total of 3 doses (Days 1, 22, and 43).
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Patients with advanced HIV disease and refractory opportunistic infections receive Sintilimab combined with standard anti-infective therapy and antiretroviral therapy (ART). Receives: Drug: Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathogen Clearance Rate
The proportion of patients achieving microbiological clearance (e.g., negative culture or negative PCR) of the specific refractory opportunistic infection.
Measured: From enrollment to the end of treatment at 9 weeks
Patient Mortality Rate
The proportion of patients who die from any cause during the study period.
Measured: From enrollment to the end of treatment at 9 weeks
Secondary outcomes (1)
Incidence of Treatment-Related Adverse Events (TRAEs)
Safety will be assessed by recording the incidence and severity of adverse events related to the study drug, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: From enrollment to the end of treatment at 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study startMay 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Public Health Clinical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jun Chen, MD, Shanghai Public Health Clinical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579247
- Sponsor's protocol ID
- 2026-S017
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underlie the results reported in the published article will be shared.