NCT07565623Not yet recruiting
Prevention of AIDS With Opportunistic Infection Paradoxical IRIS
Source: ClinicalTrials.gov · Last updated 4 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 131 (estimated)
- First submitted
- 13 Apr 2026
- Start date
- 1 May 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Shanghai Public Health Clinical Center
- Diseases
- HIV
- NCT number
- NCT07565623
What you commit to
- Study type: Interventional
- Planned participants: 131
- From 1 May 2026 to the primary completion date, 31 Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Presence of Kaposi sarcoma, pregnancy, or confirmed tuberculosis;
- Any other condition considered by the investigators to be unsuitable for participation in this study.
Lab values
- 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;
Other
- Body weight \< 40 kg;
- Pregnant or lactating women;
- Contraindications to glucocorticoid use;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.