Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia
Recruiting
Phase 2
Phase 3
Interventional Study
Cryptococcal Meningitis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 15 and older
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 356 (estimated)
- Sponsor
- Makerere University · Other
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About This Trial
This will be a randomized controlled trial of asymptomatic (Cryptococcal Antigen test)CrAg positive persons in Uganda.
Patients will be randomized to receive preemptive treatment with 1 dose of liposomal amphotericin (10mg/kg) in addition to standard of care fluconazole therapy.
How the enhanced antifungal therapy prevents progression to meningitis in the first 24-weeks and overall survival in t…
Trial Locations
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Eligibility Criteria
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 infec…
Contacts