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New treatment option for Hiv
Official title Platform Trial For Cryptococcal Meningitis (PLATFORM-CM)
ClinicalTrials.gov ID: NCT06666322
What this study is testing
What is Oteseconazole - antifungal therapy 1?
Oteseconazole - antifungal therapy 1 is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for hiv.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility 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).
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Kampala, Uganda
- Mbarara, Uganda
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kampala, Uganda; Mbarara, Uganda. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.