2000 Participants Needed

Antifungal Therapies for Cryptococcal Meningitis

(PLATFORM-CM Trial)

Recruiting at 2 trial locations
DB
Overseen ByDavid Boulware, MD, MPH
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

Cryptococcal meningitis is a fungal infection that causes a severe syndrome of meningitis that is 100% fatal without antifungal therapy. Even with antifungal therapy, mortality rates remain high, especially in low and middle income countries where the ongoing HIV/AIDS pandemic increases the risk of cryptococcosis among persons living with HIV infection. The combination of amphotericin and flucytosine (5-FC) has been the mainstay of therapy for the initial management of cryptococcal meningitis for 4 decades. Indeed, the effective delivery of these first line therapy in Africa can lower mortality to 25%. However, several challenges exist. First, even while 5-FC is included on the WHO list of essential medicines, the availability of 5-FC worldwide is limited. Second, liposomal amphotericin (Ambisome ®) is currently available from a single source supplier, creating risk. Third, current therapies have substantial toxicity. Lastly, with widespread agricultural fungicide use of azoles, the median fluconazole minimum inhibitory concentration (MIC50 ) for Cryptococcus has doubled since 2013. Globally, new or improved antifungals are needed for cryptococcal meningitis, particularly those which have less toxicity, greater efficacy, a prolonged half-life, and minimal drug-drug interactions. As multiple new antifungal medicines are on the horizon, this platform trial utilizes a master protocol to investigate, multiple regimens using standardized eligibility criteria, standardized study schedule of events, and standardized contemporary endpoints.

Research Team

DR

David R Boulware, MD, MPH

Principal Investigator

University of Minnesota

DB

David B Meya, MBChB, MMed, PhD

Principal Investigator

Uganda

Eligibility Criteria

This trial is for individuals with cryptococcal meningitis, often linked to HIV. Participants must consent to the study procedures, including lumbar punctures, and women able to become pregnant must use contraception. Those with CSF cryptococcal antigen positive meningitis are eligible.

Inclusion Criteria

I am HIV positive.
I am willing and able to give my consent for treatment.
I agree to use birth control if I can get pregnant and am sexually active.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard of care or one of the experimental antifungal therapies

2 weeks
Multiple visits for CSF sampling and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including survival and adverse events

18 weeks
Regular follow-up visits to assess survival and adverse events

Treatment Details

Interventions

  • Antifungal therapy 3
  • Antifungal therapy 4
  • Oteseconazole
  • Sfu-AM2-19 Injection
Trial Overview The trial is testing multiple antifungal therapies against cryptococcal meningitis: standard care, Oteseconazole, Sfu-AM2-19 Injection, and two other unnamed antifungals. It aims to find treatments that are less toxic and more effective.
Participant Groups
5Treatment groups
Experimental Treatment
Active Control
Group I: Experimental group 4Experimental Treatment1 Intervention
randomized to experimental antifungal therapy #4
Group II: Experimental group 3Experimental Treatment1 Intervention
randomized to experimental antifungal therapy #3
Group III: Experimental group 2Experimental Treatment1 Intervention
randomized to experimental antifungal therapy #2
Group IV: Experimental group 1Experimental Treatment1 Intervention
randomized to experimental antifungal therapy #1
Group V: Control groupActive Control1 Intervention
randomized to standard of care

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+
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