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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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).
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China
Pathogen Clearance Rate
The proportion of patients achieving microbiological clearance (e.g., negative culture or negative PCR) of the specific refractory opportunistic infection.
Time frame: 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.
Time frame: From enrollment to the end of treatment at 9 weeks
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.
Time frame: From enrollment to the end of treatment at 9 weeks
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