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Efficacy and Safety of High-dose Liposomal Amphotericin B for Disseminated Histoplasmosis in AIDS

RecruitingPhase 3

Sponsor: Federal University of Health Science of Porto Alegre

Conditions: Disseminated Histoplasma Capsulatum Infection, AIDS and Infections, Immunosuppression, Fungal Infection

Interventions: Single high dose of liposomal amphotericin B, L-AmB standard dose

Countries: Brazil

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion 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

Exclusion criteria:

* Refusal to participate in the trial
* Previous diagnosis of histoplasmosis
* Pregnant or lactating women
* Patients with renal failure at any given time (serum creatinine \&amp;gt; 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 feeding tube

Locations (5)

Goiânia, Goiás, Brazil
Natal, Rio Grande do Norte, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Boa Vista, Roraima, Brazil