HIV (Human Immunodeficiency Virus)NCT07565623
Prevention of AIDS With Opportunistic Infection Paradoxical IRIS
A study testing Prednisolone in people with HIV (Human Immunodeficiency Virus) and IRIS, run by Shanghai Public Health Clinical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV (Human Immunodeficiency Virus), IRIS
- What is being tested?
- Prednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- Prednisolone
- Keywords
- HIV, IRIS, prevention, glucocorticoid
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneDrug
Prednisolone Group
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Prednisolone |
| control group | No intervention | No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of paradoxical IRIS at 12 weeks after enrollment.
Incidence rate of paradoxical IRIS at 12 weeks after enrollment.
Measured: 12weeks
Secondary outcomes (8)
Time from enrollment to occurrence of paradoxical IRIS
Measured: within 12weeks
Duration of paradoxical IRIS
Measured: within 12 weeks
Death (related to paradoxical IRIS; all-cause mortality)
Measured: 12weeks
Hospitalization (related to paradoxical IRIS; all-cause)
Measured: 12weeks
Composite endpoint of death or hospitalization
Measured: within 12weeks
Incidence rate of serious adverse events
Measured: 12weeks
CD4+ T lymphocyte count at 12 weeks
Measured: 12weeks
Number of patients with HIV-RNA < 20 copies/ml at 12 weeks
Measured: 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV (Human Immunodeficiency Virus)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 131 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Public Health Clinical Center
- Sponsor type
- Other government
- 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
- Responsible party
- Principal investigator, Yinzhong Shen, Shanghai Public Health Clinical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07565623
- Sponsor's protocol ID
- 2025-S147-02
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30428290
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of AIDS With Opportunistic Infection Paradoxical IRIS
- ClinicalTrials.gov ID
- NCT07565623
- Acronym / sponsor ID
- 2025-S147-02
- Conditions
- HIV (Human Immunodeficiency Virus), IRIS
- Keywords
- HIV, IRIS, prevention, glucocorticoid
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 131 participants (estimated)
- Lead sponsor
- Shanghai Public Health Clinical CenterOther government
- 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
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prednisolone group | Experimental | Drug: PrednisoloneParticipants 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. |
| control group | No intervention | –No Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrednisolonePrednisolone Group | Drug | prednisolone group |
Primary outcome
Incidence rate of paradoxical IRIS at 12 weeks after enrollment.
Time frame: 12weeks
Incidence rate of paradoxical IRIS at 12 weeks after enrollment.
8 secondary outcomes
Time from enrollment to occurrence of paradoxical IRIS
Time frame: within 12weeks
Duration of paradoxical IRIS
Time frame: within 12 weeks
Death (related to paradoxical IRIS; all-cause mortality)
Time frame: 12weeks
Hospitalization (related to paradoxical IRIS; all-cause)
Time frame: 12weeks
Composite endpoint of death or hospitalization
Time frame: within 12weeks
Incidence rate of serious adverse events
Time frame: 12weeks
CD4+ T lymphocyte count at 12 weeks
Time frame: 12weeks
Number of patients with HIV-RNA < 20 copies/ml at 12 weeks
Time frame: 12weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Results publication: PubMed 30428290Meintjes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Prednisolone in people with HIV (Human Immunodeficiency Virus) and IRIS, run by Shanghai Public Health Clinical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact jia tang, MD (18974693450, tangsweetness@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of paradoxical IRIS at 12 weeks after enrollment. (time frame: 12weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07565623, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.