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Tests treatment safety and results for Disseminated Histoplasma Capsulatum Infection
Official title Efficacy and Safety of High-dose Liposomal Amphotericin B for Disseminated Histoplasmosis in AIDS
ClinicalTrials.gov ID: NCT05814432
What this study is testing
What is Single high dose of liposomal amphotericin B?
Single high dose of liposomal amphotericin B is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for disseminated histoplasma capsulatum infection.
Also referred to as L-AmB single high dose investigational arm.
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
- Phase III trial evaluating the safety and efficacy of a single high dose (10 mg/kg) of liposomal amphotericin B for disseminated histoplasmosis in AIDS patients, in comparison to standard therapy (3 mg/kg of liposomal amphotericin B for two weeks) (INDUCTION trial).
- 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
- Adult patients admitted to the centers that will be part of the study
- Infected by the HIV, regardless of the use of antiretroviral therapy
- Patients diagnosed with disseminated histoplasmosis, confirmed by classical mycological methods (microscopy, culture or histopathology) or urinary...
- Patients with central nervous system (CNS) infection may be included if they have an alternative diagnosis suggestive of another CNS infection
- Patients using fluconazole for oroesophageal candidiasis may be included
You likely can't join if
- Refusal to participate in the trial
- Previous diagnosis of histoplasmosis
- Pregnant or lactating women
- Patients with renal failure at any given time (serum creatinine \> 2x or upper limit of normality (KDIGO, 2012)
- Previous severe reaction to a polyene antifungal
- Receipt of more than one dose of a polyene antifungal in the last 48 h
See the full eligibility criteria
- Adult patients admitted to the centers that will be part of the study
- Infected by the HIV, regardless of the use of antiretroviral therapy
- Patients diagnosed with disseminated histoplasmosis, confirmed by classical mycological methods (microscopy, culture or histopathology) or urinary Histoplasma antigen detection
- Patients with central nervous system (CNS) infection may be included if they have an alternative diagnosis suggestive of another CNS infection
- Patients using fluconazole for oroesophageal candidiasis may be included
- Refusal to participate in the trial
- Previous diagnosis of histoplasmosis
- Pregnant or lactating women
- Patients with renal failure at any given time (serum creatinine \> 2x or upper limit of normality (KDIGO, 2012)
- Previous severe reaction to a polyene antifungal
- Receipt of more than one dose of a polyene antifungal in the last 48 h
- Suspected histoplasmosis involving the central nervous system
- Patients who, in the judgment of the attending physician, have the prospect of death within the next 48 hours after selection, will also be excluded
- Patients with suspected histoplasmosis involving the central nervous system (CNS), as this condition requires high doses of amphotericin B
- Patients with the prospect of death in the next 48 hours after selection
- Patients with a concomitant diagnosis of cryptococcus will be excluded, as will patients with leishmaniasis in treatment or in secondary prophylaxis with amphotericin
- Patients without the capacity to administer enteral medication-at the discretion of the principal investigator of each center-considering that these patients will not be able to use itraconazole orally or through a...
The study team makes the final eligibility decision.
Where it's taking place
- Goiânia, Goiás, Brazil
- Natal, Rio Grande do Norte, Brazil
- Porto Alegre, Rio Grande do Sul, Brazil
- Boa Vista, Roraima, Brazil
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Goiânia, Goiás, Brazil; Natal, Rio Grande do Norte, Brazil; Porto Alegre, Rio Grande do Sul, Brazil; Boa Vista, Roraima, Brazil. Enter your location above to see the nearest site and check your eligibility.
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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.