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.

Study Overview

• Status: Not yet recruiting
• Conditions: IRIS; HIV (Human Immunodeficiency Virus)
• Intervention / Treatment: Drug: Prednisolone

• Study Type: Interventional
• Enrollment (Estimated): 131
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: jia tang, MD; Phone Number: 18974693450; Email: tangsweetness@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; No Intervention
Experimental: 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.	Drug: Prednisolone; Prednisolone Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rate of paradoxical IRIS at 12 weeks after enrollment.	Incidence rate of paradoxical IRIS at 12 weeks after enrollment.	12weeks

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Shanghai Public Health Clinical Center
• Collaborators: Beijing Ditan Hospital; Peking Union Medical College Hospital; First Affiliated Hospital of Zhejiang University; The Second Hospital of Nanjing Medical University; Meng Chao Hepatobiliary Hospital of Fujian Medical University; The Third Affiliated Hospital of Kunming Medical College.; Chongqing Public Health Medical Center; Chengdu Public Health Clinical Center

Publications and helpful links

General Publications

• Meintjes G, Stek C, Blumenthal L, Thienemann F, Schutz C, Buyze J, Ravinetto R, van Loen H, Nair A, Jackson A, Colebunders R, Maartens G, Wilkinson RJ, Lynen L; PredART Trial Team. Prednisone for the Prevention of Paradoxical Tuberculosis-Associated IRIS. N Engl J Med. 2018 Nov 15;379(20):1915-1925. doi: 10.1056/NEJMoa1800762.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: April 13, 2026
• First Submitted That Met QC Criteria: April 29, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: HIV; prevention; glucocorticoid; IRIS
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Pregnadienetriols; Prednisolone
• Other Study ID Numbers: 2025-S147-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No