Prevention of AIDS With Opportunistic Infection Paradoxical IRIS

NCT07565623 | Not Yet Recruiting DMC

• 1 other identifier: 2025-S147-02
• Study Type: interventional
• Target: 131
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HIV (Human Immunodeficiency Virus); IRIS

Keywords

HIV; IRIS; prevention; glucocorticoid

Outcome Measures

Primary Outcomes (1)

• Incidence rate of paradoxical IRIS at 12 weeks after enrollment.

  Incidence rate of paradoxical IRIS at 12 weeks after enrollment.

  12weeks

Secondary Outcomes (8)

• 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

Study Arms (2)

prednisolone group

EXPERIMENTAL

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

control group

NO INTERVENTION

No Intervention

Interventions

Prednisolone DRUG

Prednisolone Group

prednisolone group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Related Publications (1)

• 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.

  PMID: 30428290 RESULT

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

jia tang, MD

CONTACT

18974693450; tangsweetness@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: May 4, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share