Clinical trials

This is a prospective, multicenter, open-label, parallel-controlled study. The primary objective is to prospectively explore and compare the virological efficacy of Ainuovirine/Lamivudine/Tenofovir and Efavirenz/Lamivudine/Tenofovir regimens combined with rifampicin and isoniazid-based anti-tuberculosis therapy in HIV-infected patients with active tuberculosis. Participants are divided into two groups to compare the virological suppression rate and immunological efficacy between the two antiretroviral regimens. All subjects will receive continuous antiretroviral medication and anti-tuberculosis drugs under medical supervision throughout the study.

This study adopts a multicenter, open-label, randomized controlled design, conducted across key designated AIDS diagnosis and treatment hospitals nationwide. It aims to compare the efficacy and safety of the 2HPMZ/2HPM regimen versus the 2HRZE/4HR regimen in treating HIV-associated drug-susceptible pulmonary tuberculosis (DS-TB) among patients with a CD4+ T-cell count \< 100 cells/μL. A total of 148 participants will be enrolled and randomized 1:1 into two groups: 74 cases in the 2HPMZ/2HPM group and 74 cases in the 2HRZE/4HR group.

Background: Disseminated Mycobacterium avium complex (MAC) infection remains a serious opportunistic infection in patients with advanced HIV infection, particularly among those with severe immunosuppression. Despite the widespread use of antiretroviral therapy (ART), disseminated MAC (DMAC) continues to be associated with significant morbidity and mortality. The current standard treatment consists of a macrolide-based triple regimen, including a macrolide, ethambutol, and rifamycin. However, in patients with high mycobacterial burden or profound immunodeficiency, early microbiological response and clinical improvement are often suboptimal, and treatment is complicated by drug interactions and tolerability issues. Objective: This study aims to evaluate whether adding a fluoroquinolone (levofloxacin or moxifloxacin) to the standard triple therapy improves early clinical outcomes in HIV-infected patients with disseminated MAC infection. Methods: This is a prospective, multicenter, randomized, open-label, controlled trial. A total of 124 adult HIV-infected patients with confirmed disseminated MAC infection will be randomly assigned in a 1:1 ratio to receive either standard triple therapy (macrolide, ethambutol, and rifamycin) or an intensified four-drug regimen with the addition of a fluoroquinolone during the initial 8-week intensive phase. Participants will be followed for at least 24 weeks. Outcomes: The primary endpoint is the clinical symptom resolution rate at Day 28. Secondary endpoints include microbiological outcomes (culture or molecular conversion at Days 28, 56, and 84), time to culture conversion, mortality, relapse, and safety outcomes including adverse events and QT interval prolongation. Significance: This study will provide prospective evidence on whether an intensified treatment strategy can improve early clinical response and microbiological clearance in disseminated MAC infection, while maintaining an acceptable safety profile. The findings may help optimize treatment strategies for HIV-associated disseminated MAC infection.

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.

This study was a multicenter, open-label, randomized controlled clinical trial designed to evaluate the efficacy and safety of glucocorticoids in preventing paradoxical immune reconstitution inflammatory syndrome (IRIS) in patients with AIDS complicated by opportunistic infections. A total of 262 HIV-infected patients with a baseline CD4⁺ T-cell count \<100/μL, who were scheduled to initiate antiretroviral therapy and had opportunistic infections, were enrolled and randomly assigned in a 1:1 ratio to the prednisolone group or the control group. Participants in the treatment group received prednisolone at 40 mg/day for 14 days followed by 20 mg/day for 14 days, whereas the control group received no glucocorticoid intervention. All participants were followed for 12 weeks. The primary endpoint was the incidence of paradoxical IRIS within 12 weeks. Secondary endpoints included time to IRIS onset, duration of IRIS, mortality, hospitalization, serious adverse events, CD4⁺ T-cell counts, and HIV-RNA suppression. The findings will provide evidence-based support for the prevention of paradoxical IRIS.

This study stratified and compared the differences in virological efficacy and sustained viral suppression status between HIV-infected patients with and without opportunistic infections, providing a basis for optimizing antiretroviral therapy for opportunistic infections and a data foundation for establishing predictive models.

Invariant Natural killer T (iNKT) cells are a unique subset of lymphocytes that express homogeneous TCR recognizing KRN7000 which was up-regulated by many kinds of cancer cells. PD-1+CD8+T cells of patients with advanced tumor are most likely tumor-specified. Our hypothesis is that immunotherapy strategy of infusion of iNKT cells and PD-1+CD8+T cells may decrease the tumor burden and improve overall survival. The purpose of this study is to assess the safety and efficacy of treatment of patients with advanced solid tumor by infusing of iNKT cells and PD-1+CD8+T cells.

This study aims to compare the efficacy and safety of a single high-dose Liposomal Amphotericin B (L-AMB) against conventional Amphotericin B deoxycholate (AmBD) for HIV-associated Talaromycosis. The investigators hypothesize that L-AMB induction therapy (10 mg/kg) is non-inferior to AmBD (0.5-0.7 mg/kg/d) in efficacy and has an improved safety profile. The study's primary objective is to provide evidence supporting the guideline recommendation of single high-dose L-AMB for HIV-infected individuals with talaromycosis, while validating L-AMB's efficacy and safety in China. Study Design: Multi-center, randomized controlled trial comparing single high-dose L-AMB to guideline-recommended AmBD induction therapy for HIV-associated talaromycosis. Participants are HIV-infected adults (≥18 years) with confirmed talaromycosis by microscopy or culture. Interventions: 1. L-AMB group receives a single intravenous dose of 10 mg/kg L-AMB. 2. Control group receives intravenous AmBD at 0.5-0.7 mg/kg/d for 14 days. 3. Both groups start consolidation therapy with itraconazole 200mg q12h for 10 weeks within 24 hours post-induction. 4. Secondary prophylaxis with itraconazole 200mg qd until CD4+ cell counts exceed 100cells/mm³ for at least 6 months. 5. All start B/F/TAF qd within 7 days post-antifungal therapy. Primary Objective： This multicenter study compares efficacy/safety of single high-dose L-AMB vs standard AmBD (2-week) induction for HIV-associated talaromycosis, generating evidence to support L-AMB guidelines in Chinese populations. Secondary Objectives： Evaluate feasibility/safety of initiating B/F/TAF within 7 days post-antifungal therapy, providing evidence for rapid ART guidelines in these patients. Endpoints: * Primary: Proportion achieving clinical resolution on day 14. * Secondary: Overall survival, renal function, anemia, liver function, adverse events grade 3 or higher on day 14; time to clinical resolution and sterile blood cultures; survival, HIV viral suppression, CD4+ T-cell counts, adverse events (including IRIS), ART persistency, and patient-reported outcomes at weeks 4, 12, and 24. Sample Size: 58 participants per group (116 total), considering a 10% dropout rate.

The goal of this clinical trial is to learn if the SARS-CoV-2 subunit mucosal vaccine with the recombinant flagellin protein adjuvant works to Prevent COVID-19 infection. It will also learn about the Safety and immunogenicity of the vaccine.

To investigate the efficacy and tolerability of the regimen of dolutegravir plus lamivudine in HIV infected adults who are virologically suppressed and with evidence of TDF toxicity.