Comparing antifungal treatment options for cryptococcal meningitis in people with HIV.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2/3 platform trial randomly assigns adults living with HIV and CSF cryptococcal antigen–positive meningitis to one of several antifungal regimens, including standard of care and investigational agents such as oteseconazole and Sfu-AM2-19. The platform design allows treatment arms to be added or dropped based on safety and early efficacy signals, with participants receiving protocol-specified lumbar punctures and close clinical follow-up. Key outcomes include mortality, drug-related toxicity, and the feasibility of delivering therapies in low-resource settings. The goal is to find regimens that are safer, more accessible, or more effective than current amphotericin-based approaches.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* CSF cryptococcal antigen (CrAg) positive meningitis
* Living with HIV
* Ability and willingness to provide informed consent
* Willing to receive protocol-specified lumbar punctures
* Age \>= 18 years
* Female participants of childbearing potential who are participating in sexual activity that could lead to pregnancy must agree to use reliable forms of contraception (duration will be indicated in each Trial Appendix).

Exclusion Criteria:

* Received 3 or more doses of antifungal therapy for meningitis within last 30 days
* Inability to take enteral (oral or nasogastric) medicine
* Cannot or unlikely to attend regular clinic visits
* Receiving chemotherapy or corticosteroids
* Receiving hemodialysis or known liver cirrhosis
* Suspected Paradoxical immune reconstitution inflammatory syndrome (IRIS)
* Pregnancy or breastfeeding
* Previous administration of investigational study drug
* Any condition for which participation would not be in the best interest of the participant or that could limit protocol specified assessments
* Trial Appendix study-drug specific eligibility criteria

Where it's running

• Infectious Diseases Institute
  Kampala, Uganda Recruiting
• Mbarara University of Science and Technology
  Mbarara, Uganda Recruiting

Study contacts

• Principal investigator: David R Boulware, MD, MPH — University of Minnesota
• Study coordinator: David Boulware, MD, MPH
• Email: coat.trial@gmail.com
• Phone: 612-624-9996

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.