Efficacy and Safety of High-dose Liposomal Amphotericin B for Disseminated Histoplasmosis
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).
| Condition(s) | Disseminated Histoplasma Capsulatum Infection, AIDS and Infections, Immunosuppression, Fungal Infection |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | 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 can participate | 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 (KDI |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Federal University of Health Science of Porto Alegre |
| Locations | 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 |
| Start date | 2025-01-16 |
| NCT ID | NCT05814432 |
| Official listing | https://clinicaltrials.gov/study/NCT05814432 |