Evaluation of CrAg Screening With Enhanced Antifungal Therapy for Asymptomatic CrAg+ Persons
Who is this study for? People in Uganda who are asymptomatic CrAg positive
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 15
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Uganda
infectious Disease Institute Kampala,Uganda
RECRUITING
Kampala
Contact Information
Primary
DAVID MEYA, PhD
david.meya@gmail.com
+256 772 543 730
Backup
ELIZABETH NALINTYA, MPH
enalintya@idi.co.ug
+256 771 321 617
Time Frame
Start Date: 2019-06-20
Estimated Completion Date: 2028-04
Participants
Target number of participants: 356
Treatments
Experimental: Single dose liposomal Amphotericin and fluconazole
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)
Active_comparator: fluconazole (standard of care)
Standard of care pre-emptive treatment fluconazole 800mg for two weeks ,400mg for 8 weeks and 200mg upto 6 months
Related Therapeutic Areas
Sponsors
Leads: Makerere University
Collaborators: Gilead Sciences, University of Minnesota