Prevention of AIDS With Opportunistic Infection Paradoxical IRIS

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.

NCT Number	NCT07565623
Lead Sponsor	Shanghai Public Health Clinical Center Collaborators: 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
Conditions	HIV (Human Immunodeficiency Virus), IRIS
Enrollment	131 participants
Start Date	2026-05-01
Primary Completion	2027-12-31 (estimated)
Study Completion	2028-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-05-04