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New treatment option for Cryptococcal Meningitis
Official title Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia
ClinicalTrials.gov ID: NCT03945448
What this study is testing
What is Single dose liposomal Amphotericin and Fluconazole?
Single dose liposomal Amphotericin and Fluconazole is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cryptococcal meningitis.
Also referred to as AMBISOME and fluconazole.
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
- This will be a randomized controlled trial of asymptomatic (Cryptococcal Antigen test)CrAg positive persons in Uganda. Patients will be randomized to receive preemptive treatment with 1 dose of liposomal amphotericin (10mg/kg) in addition to standard of care fluconazole therapy.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 15 and older
You may be able to join if
- HIV-1 infection
- Age \> or equal to15 years
- Ability and willingness to give informed consent.
- Plasma/Serum cryptococcal antigen (CRAG)+ with a titer 1:160 or greater
You likely can't join if
- Cannot or unlikely to attend regular clinic visits
- History of cryptococcal infection
- Symptomatic meningitis (confirmed by CSF CRAG+)
- \>14 days of fluconazole therapy
- Pregnancy (confirmed by urinary or serum pregnancy test)
- Current breastfeeding
See the full eligibility criteria
- HIV-1 infection
- Age \> or equal to15 years
- Ability and willingness to give informed consent.
- Plasma/Serum cryptococcal antigen (CRAG)+ with a titer 1:160 or greater
- Cannot or unlikely to attend regular clinic visits
- History of cryptococcal infection
- Symptomatic meningitis (confirmed by CSF CRAG+)
- \>14 days of fluconazole therapy
- Pregnancy (confirmed by urinary or serum pregnancy test)
- Current breastfeeding
- Known allergy to amphotericin
The study team makes the final eligibility decision.
Where it's taking place
- Kampala, 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, 15 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kampala, 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.