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Can one Mega-Dose of an antifungal beat a deadly infection in AIDS patients?

NCT ID NCT05814432

Disease control Sponsor: Federal University of Health Science of Porto Alegre Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time

Summary

This phase III trial is testing whether a single high dose (10 mg/kg) of liposomal amphotericin B can safely and effectively treat disseminated histoplasmosis, a serious fungal infection, in adults with AIDS. The standard treatment requires two weeks of daily infusions. The study compares the single-dose approach to the standard regimen, measuring survival and side effects. If successful, it could simplify treatment and reduce hospital stays.

What this could mean

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

Active substance
a single high dose of liposomal amphotericin B
What this could lead to
If it works, a single high dose could replace the current two-week standard treatment, making therapy simpler and faster for a deadly fungal infection in people with AIDS.
What could go wrong
This is an early-phase trial, so the high dose may cause more side effects like kidney problems or electrolyte imbalances, and it might not be as effective as the standard regimen.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 279 people

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

Started

Jan 2025

Expected to finish

Jul 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Adult patients admitted to the centers that will be part of the study * Infected by the HIV, regardless of the use of antiretroviral therapy * Patients diagnosed with disseminated histoplasmosis, confirmed by classical mycological methods (microscopy, culture or histopathology) or urinary Histoplasma antigen detection * Patients with central nervous system (CNS) infection may be included if they have an alternative diagnosis suggestive of another CNS infection * Patients using fluconazole for oroesophageal candidiasis may be included Exclusion criteria: * Refusal to participate in the trial * Previous diagnosis of histoplasmosis * Pregnant or lactating women * Patients with renal failure at any given time (serum creatinine \> 2x or upper limit of normality (KDIGO, 2012) * Previous severe reaction to a polyene antifungal * Receipt of more than one dose of a polyene antifungal in the last 48 h * Suspected histoplasmosis involving the central nervous system * Patients who, in the judgment of the attending physician, have the prospect of death within the next 48 hours after selection, will also be excluded * Patients with suspected histoplasmosis involving the central nervous system (CNS), as this condition requires high doses of amphotericin B * Patients with the prospect of death in the next 48 hours after selection * Patients with a concomitant diagnosis of cryptococcus will be excluded, as will patients with leishmaniasis in treatment or in secondary prophylaxis with amphotericin * Patients without the capacity to administer enteral medication-at the discretion of the principal investigator of each center-considering that these patients will not be able to use itraconazole orally or through a feeding tube

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Conditions

The condition(s) this trial relates to.

AIDS fungal infectious disease histoplasmosis HIV infectious disease Infections

As listed by the trial registrant

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

AIDS and infections Disseminated histoplasma capsulatum infection Fungal infection Immunosuppression

How to take part

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

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • Federal University of Health Sciences of Porto Alegre

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

  • Hospital Geral de Roraima

    RECRUITING

    Boa Vista, Roraima, Brazil

  • Hospital Giselda Trigueiro

    RECRUITING

    Natal, Rio Grande do Norte, Brazil

  • Hospital de Clinicas de Porto Alegre

    RECRUITING

    Porto Alegre, Rio Grande do Sul, Brazil

  • Hospital de Doenças Tropicais

    RECRUITING

    Goiânia, Goiás, Brazil

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