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Could a single shot stop deadly meningitis in HIV patients?

NCT ID NCT03945448

Disease control Sponsor: Makerere University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests whether adding one dose of a stronger antifungal drug (liposomal amphotericin) to the standard treatment (fluconazole) can prevent cryptococcal meningitis in HIV-positive adults who test positive for the fungus but have no symptoms. About 356 participants in Uganda will be randomly assigned to receive either the enhanced therapy or standard care alone. The goal is to see if the stronger treatment reduces the number of people who develop meningitis over 24 weeks.

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 356 people

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

Started

Jun 2019

Expected to finish

Aug 2027

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

15 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: * HIV-1 infection * Age \> or equal to15 years * Ability and willingness to give informed consent. * Plasma/Serum cryptococcal antigen (CRAG)+ with a titer 1:160 or greater Exclusion Criteria: * Cannot or unlikely to attend regular clinic visits * History of cryptococcal infection * Symptomatic meningitis (confirmed by CSF CRAG+) * \>14 days of fluconazole therapy * Pregnancy (confirmed by urinary or serum pregnancy test) * Current breastfeeding * Known allergy to amphotericin

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Conditions

The condition(s) this trial relates to.

HIV infectious disease Cryptococcal meningitis prevention target

As listed by the trial registrant

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

Cryptococcal meningitis

How to take part

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

  1. The places running it

    1 site. 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 Disease Institute Kampala,Uganda

    RECRUITING

    Kampala, Uganda

More trials for these conditions

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