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Could a common steroid prevent a deadly complication in AIDS patients?

NCT ID NCT07565623

Prevention Sponsor: Shanghai Public Health Clinical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a short course of the steroid prednisolone can prevent paradoxical immune reconstitution inflammatory syndrome (IRIS) in people with AIDS who have low CD4 counts and are starting HIV treatment. About 131 participants will receive either prednisolone or no extra treatment and be followed for 12 weeks. The goal is to see if the steroid reduces the risk of this serious inflammatory reaction.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Prednisolone
What this could lead to
If successful, this could provide a simple, short-term steroid treatment to prevent a dangerous inflammatory complication in people with AIDS starting HIV therapy.
What could go wrong
This is an early-stage trial with only 131 participants, and steroids have known side effects like increased infection risk. The results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 131 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

AIDS Cryptococcal meningitis cytomegalovirus retinitis HIV infectious disease penicilliosis pneumocystosis progressive multifocal leukoencephalopathy pulmonary non-tuberculous mycobacterial infection immune reconstitution inflammatory syndrome prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV (human immunodeficiency virus) IRIS

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.