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New hope against a deadly brain infection: large trial tests safer antifungals

NCT ID NCT06666322

Disease control Sponsor: David Boulware 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jul 28, 2026 · Updated 2 times

Summary

This large platform trial is testing new antifungal drug combinations for cryptococcal meningitis, a severe brain infection that is fatal without treatment and common in people with HIV. The study will enroll 2,000 participants across multiple sites to compare a newer oral drug, oteseconazole, against standard therapy. The goal is to find treatments that are less toxic, more effective, and easier to access worldwide.

What this could mean

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

Active substance
Oteseconazole (an oral antifungal drug) compared to standard therapy (liposomal amphotericin B, flucytosine, fluconazole)
What this could lead to
If successful, this could provide safer, more effective, and more accessible treatments for cryptococcal meningitis, potentially lowering the high death rate in low-resource settings.
What could go wrong
This is an early-to-mid-stage platform trial, so results are not guaranteed. New drugs may have unexpected side effects or fail to outperform existing therapies.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 2,000 people

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

Started

May 2025

Expected to finish

Apr 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: * CSF cryptococcal antigen (CrAg) positive meningitis * Living with HIV * Ability and willingness to provide informed consent * Willing to receive protocol-specified lumbar punctures * Age \>= 18 years * Female participants of childbearing potential who are participating in sexual activity that could lead to pregnancy must agree to use reliable forms of contraception (duration will be indicated in each Trial Appendix). Exclusion Criteria: * Received 3 or more doses of antifungal therapy for meningitis within last 30 days * Inability to take enteral (oral or nasogastric) medicine * Cannot or unlikely to attend regular clinic visits * Receiving chemotherapy or corticosteroids * Receiving hemodialysis or known liver cirrhosis * Suspected Paradoxical immune reconstitution inflammatory syndrome (IRIS) * Pregnancy or breastfeeding * Previous administration of investigational study drug * Any condition for which participation would not be in the best interest of the participant or that could limit protocol specified assessments * Trial Appendix study-drug specific eligibility criteria

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

AIDS Cryptococcal meningitis HIV infectious disease

As listed by the trial registrant

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

Cryptococcal meningitis HIV

How to take part

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

  1. The places running it

    2 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

  • Infectious Diseases Institute

    RECRUITING

    Kampala, Uganda

  • Mbarara University of Science and Technology

    RECRUITING

    Mbarara, Uganda

More trials for these conditions

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