Platform Trial For Cryptococcal Meningitis

Launched by UNIVERSITY OF MINNESOTA · Oct 29, 2024

Keywords

ClinConnect Summary

This clinical trial is designed to study new treatment options for cryptococcal meningitis, a serious fungal infection that can be life-threatening, especially for people living with HIV. The trial aims to find more effective and safer antifungal medications since current treatments can be hard to access and may cause significant side effects. Researchers will evaluate various treatment combinations to see which ones work best while being easier on patients.

To participate in this trial, individuals must be at least 18 years old, have a confirmed diagnosis of cryptococcal meningitis, and be HIV positive. Participants will need to be willing to undergo certain medical procedures and provide informed consent. Throughout the trial, patients can expect to receive close monitoring and care as they try new treatment options. This study is crucial because it aims to improve the outcomes for those affected by this disease, especially in regions where access to effective treatments is limited.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • CSF cryptococcal antigen (CrAg) positive meningitis
• • HIV positive
• • 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 doses of antifungal therapy for meningitis treatment or \> 6mg/kg of liposomal amphotericin B cumulatively within prior 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