RECRUITINGPhase 3INTERVENTIONAL
Efficacy and Safety of High-dose Liposomal Amphotericin B for Disseminated Histoplasmosis in AIDS
Efficacy and Safety of High-dose Liposomal Amphotericin B (10 Mg/kg) for Disseminated Histoplasmosis in AIDS: a Randomized Phase III Trial (INDUCTION Trial)
About This Trial
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).
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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 feeding tube
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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 \> 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
Treatments Being Tested
DRUG
Single high dose of liposomal amphotericin B
Single high dose (10 mg/kg) of liposomal amphotericin B as induction therapy for disseminated histoplasmosis in AIDS
DRUG
L-AmB standard dose
Standard treatment (3 mg/kg for two weeks) with liposomal amphotericin B as induction therapy for disseminated histoplasmosis in AIDS
Locations (5)
Hospital de Doenças Tropicais
Goiânia, Goiás, Brazil
Hospital Giselda Trigueiro
Natal, Rio Grande do Norte, Brazil
Federal University of Health Sciences of Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Geral de Roraima
Boa Vista, Roraima, Brazil