High-dose Liposomal Amphotericin B for treating disseminated histoplasmosis in AIDS patients
Efficacy and Safety of High-dose Liposomal Amphotericin B (10 Mg/kg) for Disseminated Histoplasmosis in AIDS: a Randomized Phase III Trial (INDUCTION Trial)
This study is testing if a single high dose of a medication can safely treat disseminated histoplasmosis in AIDS patients better than the usual lower dose given over two weeks.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 279 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Federal University of Health Science of Porto Alegre Academic / other |
| Locations | 5 sites (Goiânia, Goiás and 4 other locations) |
| Trial ID | NCT05814432 on ClinicalTrials.gov |
What this trial studies
This phase III trial evaluates the safety and efficacy of a single high dose of liposomal amphotericin B (10 mg/kg) compared to the standard therapy dose (3 mg/kg for two weeks) in patients with disseminated histoplasmosis associated with AIDS. The study aims to determine non-inferiority in terms of two-week mortality and superiority in a Desirability of Outcome Ranking (DOOR). It includes adult patients diagnosed with disseminated histoplasmosis, confirmed through various mycological methods. The trial will also establish a Data Safety Monitoring Board to oversee participant safety and efficacy throughout the study duration.
Who should consider this trial
Good fit: Ideal candidates are adult patients with HIV who have been diagnosed with disseminated histoplasmosis.
Not a fit: Patients with previous diagnoses of histoplasmosis or those with renal failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and accessible option for patients suffering from disseminated histoplasmosis in the context of AIDS.
How similar studies have performed: Previous phase II trials have shown promising results with high-dose liposomal amphotericin B, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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 \> 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
Where this trial is running
Goiânia, Goiás and 4 other locations
- Hospital de Doenças Tropicais — Goiânia, Goiás, Brazil (Recruiting)
- Hospital Giselda Trigueiro — Natal, Rio Grande do Norte, Brazil (Recruiting)
- Federal University of Health Sciences of Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil (Recruiting)
- Hospital de Clinicas de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil (Recruiting)
- Hospital Geral de Roraima — Boa Vista, Roraima, Brazil (Recruiting)
Study contacts
- Study coordinator: Alessandro C Pasqualotto, MD PhD
- Email: acpasqualotto@hotmail.com
- Phone: +5551999951614
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.