Prevention of AIDS With Opportunistic Infection Paradoxical IRIS
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 131
- 主要终点
- Incidence rate of paradoxical IRIS at 12 weeks after enrollment.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years;
- •Confirmed HIV infection;
- •Presence of HIV-related opportunistic infection(s), including non-tuberculous -mycobacterial infection, PJP, pneumonia, cryptococcal meningitis, Talaromyces marneffei infection, CMV retinitis, or PML;
- •Baseline CD4 T-lymphocyte count < 100 cells/μL;
- •Planned initiation of antiretroviral therapy;
- •Willing to participate in this study, able to comply with all follow-up requirements, and able to provide written informed consent.
排除标准
- •Presence of Kaposi sarcoma, pregnancy, or confirmed tuberculosis;
- •Body weight < 40 kg;
- •Severe hepatic dysfunction (ALT or AST > 5 times the upper limit of normal, ULN);
- •Severe renal dysfunction (eGFR < 30 mL/min/1.73 m²);
- •Baseline electrocardiogram (ECG) showing a QTc interval > 500 ms;
- •Pregnant or lactating women;
- •Contraindications to glucocorticoid use;
- •Any other condition considered by the investigators to be unsuitable for participation in this study.
研究组 & 干预措施
prednisolone 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.
干预措施: Prednisolone (Drug)
control group
No Intervention
结局指标
主要结局
Incidence rate of paradoxical IRIS at 12 weeks after enrollment.
时间窗: 12weeks
Incidence rate of paradoxical IRIS at 12 weeks after enrollment.
次要结局
- Time from enrollment to occurrence of paradoxical IRIS(within 12weeks)
- Duration of paradoxical IRIS(within 12 weeks)
- Death (related to paradoxical IRIS; all-cause mortality)(12weeks)
- Hospitalization (related to paradoxical IRIS; all-cause)(12weeks)
- Composite endpoint of death or hospitalization(within 12weeks)
- Incidence rate of serious adverse events(12weeks)
- CD4+ T lymphocyte count at 12 weeks(12weeks)
- Number of patients with HIV-RNA < 20 copies/ml at 12 weeks(12weeks)
研究者
Yinzhong Shen
MD
Shanghai Public Health Clinical Center