Platform Trial For Cryptococcal Meningitis

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

2,000

Participants

Timeline

Start Date

May 28, 2025

Primary Completion Date

April 21, 2032

Study Completion Date

April 21, 2032

Conditions
HivCryptococcal Meningitis
Interventions
DRUG

Standard of care

"2022 WHO First Line Induction Therapy:~1. Liposomal Amphotericin B 10mg/kg IV given once~2. Flucytosine 100mg/kg/day for 14 days in divided doses~3. Fluconazole 1200mg/day for 14 days Consolidation Therapy: Fluconazole 800mg/day from 2 to 10 weeks Secondary Prophylaxis: Fluconazole 200mg/day through 1 year minimum"

DRUG

Oteseconazole - antifungal therapy 1

"Oteseconazole, is an azole metalloenzyme inhibitor targeting the fungal sterol, 14α demethylase (CYP51)~* Loading doses of oral Oteseconazole 600 mg twice daily for 10 days, then 600 mg oteseconazole weekly on weeks 3, 4, 5, and 6.~* Liposomal Amphotericin B 10 mg/kg IV once.~* No fluconazole or 5FC to be given."

DRUG

Sfu-AM2-19 Injection - antifungal therapy 2

Ambisome 10 mg/kg IV administered once Fluconazole 1200mg/day and flucytosine 100mg/day in divided doses x 14 days OR SF001 1.5 mg/kg IV administered on day 1, followed by 1.5 mg/kg on day 8 Fluconazole 1200mg/day and flucytosine 100mg/day in divided doses x 14 days OR SF001 2.0 mg/kg IV administered on day 1, followed by 1.5 mg/kg on day 8 Fluconazole 1200mg/day and flucytosine 100mg/day in divided doses x 14 days

DRUG

Antifungal therapy 3

To be determined

DRUG

Antifungal therapy 4

To be determined

Trial Locations (2)

Unknown

RECRUITING

Infectious Diseases Institute, Kampala

RECRUITING

Mbarara University of Science and Technology, Mbarara

All Listed Sponsors
lead

University of Minnesota

OTHER

NCT06666322 - Platform Trial For Cryptococcal Meningitis | Biotech Hunter | Biotech Hunter