Efficacy and Safety of Immune Checkpoint Inhibitors for Refractory Opportunistic Infections in AIDS

May 6, 2026 updated by: Jun Chen, MD, Shanghai Public Health Clinical Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 201508
        • Shanghai Public Health Clinical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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:

  1. 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.
  2. Cytomegalovirus (CMV): Blood/body fluid CMV-DNA decrease <1 log10 or new/worsening organ damage after 2 weeks of Ganciclovir or Foscarnet therapy.
  3. Mpox virus: Unhealed lesions, new lesions, necrotic coalescence, or no decrease in viral load after 14 days of Tecovirimat, Cidofovir, or Brincidofovir therapy.
  4. Progressive Multifocal Leukoencephalopathy (PML): Continuous deterioration of neurological symptoms or expanded lesion area on MRI after 3 months of optimized antiretroviral therapy (ART).
  5. Pneumocystis jirovecii pneumonia (PCP): No improvement in oxygenation index or expanded radiological lesions after 8 days of adequate SMZ-TMP therapy.
  6. Cryptococcal meningitis: Persistently positive cerebrospinal fluid (CSF) culture after 4 weeks of induction therapy.
  7. Talaromyces marneffei / Invasive Aspergillosis: Persistently positive culture or progression of radiological/clinical symptoms after 2 weeks of Amphotericin B or Voriconazole therapy.
  8. Mycobacterium tuberculosis (TB): Persistently positive sputum smear or culture after 2 months of standard anti-tuberculosis therapy.
  9. 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 Criteria:

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment Group
Patients with advanced HIV disease and refractory opportunistic infections receive Sintilimab combined with standard anti-infective therapy and antiretroviral therapy (ART).
Drug: Sintilimab
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pathogen Clearance Rate
Time Frame: From enrollment to the end of treatment at 9 weeks
The proportion of patients achieving microbiological clearance (e.g., negative culture or negative PCR) of the specific refractory opportunistic infection.
From enrollment to the end of treatment at 9 weeks
Patient Mortality Rate
Time Frame: From enrollment to the end of treatment at 9 weeks
The proportion of patients who die from any cause during the study period.
From enrollment to the end of treatment at 9 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Related Adverse Events (TRAEs)
Time Frame: From enrollment to the end of treatment at 9 weeks
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.
From enrollment to the end of treatment at 9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Public Health Clinical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026-S017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) that underlie the results reported in the published article will be shared.

IPD Sharing Time Frame

Data will become available beginning 6 months and ending 36 months following article publication.

IPD Sharing Access Criteria

Data will be shared with qualified researchers who provide a methodologically sound proposal. Data will be used only to achieve the aims specified in the approved proposal. Proposals should be directed to the principal investigator or corresponding author via email. To gain access, data requestors will need to sign a formal data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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