HIV (Human Immunodeficiency Virus), IRIS
Conditions
Keywords
HIV, IRIS, prevention, glucocorticoid
Brief summary
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.
Interventions
DRUGPrednisolone
Prednisolone Group
Sponsors
Shanghai Public Health Clinical Center
Beijing Ditan Hospital
Meng Chao Hepatobiliary Hospital of Fujian Medical University
Chengdu Public Health Clinical Center
The Third Affiliated Hospital of Kunming Medical College.
Chongqing Public Health Medical Center
The Second Hospital of Nanjing Medical University
First Affiliated Hospital of Zhejiang University
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of paradoxical IRIS at 12 weeks after enrollment. | 12weeks | Incidence rate of paradoxical IRIS at 12 weeks after enrollment. |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Contacts
CONTACTjia tang, MD
Outcome results
None listed