Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia (ACACIA)

Makerere University

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Cryptococcal Meningitis

Treatments: Drug: Fluconazole; Drug: Single dose liposomal Amphotericin and Fluconazole

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03945448

ST/225/2018

Details and patient eligibility

About

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.

Enrollment: 356 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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356 participants in 2 patient groups

Single dose liposomal Amphotericin and fluconazole

Experimental group

Description:

Experimental: Single dose Ambisome 10mg/kg and Fluconazole 800mg for two weeks ,400mg for 8 weeks and 200mg upto 6 months. (standard of care therapy)

Treatment:

Drug: Single dose liposomal Amphotericin and Fluconazole

fluconazole (standard of care)

Active Comparator group

Description:

Standard of care pre-emptive treatment fluconazole 800mg for two weeks ,400mg for 8 weeks and 200mg upto 6 months

Treatment:

Drug: Fluconazole