Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia
ConditionCryptococcal Meningitis
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age15+
SponsorMakerere University
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 those who receive the intervention compared with participants receiving fluconazole per World Health Organisation (WHO) and national standard of care therapy will be evaluated.
Eligibility criteria
Qualifiers
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
Disqualifiers
Cannot or unlikely to attend regular clinic visits
History of cryptococcal infection
Symptomatic meningitis (confirmed by CSF CRAG+)
>14 days of fluconazole therapy
Trial design
Treatments tested in this trial
- Single dose liposomal Amphotericin and Fluconazole
- Fluconazole
Treatment groups
356 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov