Sintilimab for Hard-to-Treat Infections in People With Advanced HIV
Tests sintilimab alongside usual treatment in adults with advanced HIV and stubborn infections.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Immune Checkpoint Inhibitors for Refractory Opportunistic Infections in AIDS
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults living with HIV-1 who have a hard-to-treat opportunistic infection and signs of tired immune T-cells. They get Sintilimab with their usual infection treatment.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Advanced HIV disease with at least one opportunistic infection (such as CMV, PCP, tuberculosis, cryptococcal meningitis) that has not responded to standard treatment.
- Earlier treatment
- Standard treatment for the infection must have been tried without enough effect. No earlier immune checkpoint inhibitor. No immune-modifying or immune-suppressing treatment (glucocorticoids excepted) in the 24 weeks before the first dose.
- Biomarker or test result
- High PD-1 on CD8+ T cells (more than 25%) or a weak ELISpot response to the germ (less than 50 SFCs/10^6 cells).
Main reasons for not taking part
- Active autoimmune disease, or autoimmune disease needing treatment of the whole body
- Earlier organ or stem cell transplant
- Pregnant or breastfeeding
- Known allergy to the study drug
- Uncontrolled severe heart, liver or kidney failure
Read by machine on 12 November 2026.
Where in China
- Shanghai Public Health Clinical CenterShanghai, ChinaContact: Jun ChenNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Shanghai Public Health Clinical Center
- Trial code
- NCT07579247
- Record updated
- 12 May 2026
- Original description
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 full original descriptionShow less
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.
Inclusion: 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); 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.
Exclusion: 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; History of active autoimmune disease or autoimmune disease requiring systemic treatment; 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).