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NCT Number: NCT07565623

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.

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Key information

Conditions

HIV (Human Immunodeficiency Virus) Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections IRIS Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prednisolone

Drug

Prednisolone Group

Primary outcomes

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

    Time frame: 12weeks

    Incidence rate of paradoxical IRIS at 12 weeks after enrollment.

Secondary outcomes

  1. Time from enrollment to occurrence of paradoxical IRIS

    Time frame: within 12weeks

  2. Duration of paradoxical IRIS

    Time frame: within 12 weeks

  3. Death (related to paradoxical IRIS; all-cause mortality)

    Time frame: 12weeks

  4. Hospitalization (related to paradoxical IRIS; all-cause)

    Time frame: 12weeks

  5. Composite endpoint of death or hospitalization

    Time frame: within 12weeks

  6. Incidence rate of serious adverse events

    Time frame: 12weeks

  7. CD4+ T lymphocyte count at 12 weeks

    Time frame: 12weeks

  8. Number of patients with HIV-RNA < 20 copies/ml at 12 weeks

    Time frame: 12weeks

Study contacts

Contact information is provided by the study sponsor or research team.

jia tang, MD

CONTACT

[email protected]

18974693450

Sponsors and collaborators

Lead sponsor

Shanghai Public Health Clinical Center

Other Gov

Collaborators

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

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 4, 2026
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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