Phase III Study Comparing a Single High Dose vs. Standard Therapy of Liposomal Amphotericin B for Treating Disseminated Histoplasmosis in Adults with AIDS

What this Trial Is About

This trial is evaluating the safety and effectiveness of a single high dose of liposomal amphotericin B compared to the standard two-week treatment for disseminated histoplasmosis in patients with AIDS. Disseminated histoplasmosis is a serious fungal infection common in immunocompromised individuals, especially those with advanced HIV. The study aims to determine if the single high dose is at least as effective as the standard treatment in reducing mortality and improving outcomes. Participants will be randomly assigned to receive either a single high dose 10 mgkg of liposomal amphotericin B or the standard daily dose 3 mgkg for two weeks. After induction therapy, all patients will receive oral itraconazole for one year. The study includes safety monitoring by a Data Safety Monitoring Board and oversight by steering and medical committees with scheduled meetings to review progress and maintain quality. During the study, participants will be assessed for overall survival at 14 days, clinical response, fungal load, and treatment-related side effects. Additional evaluations include a Desirability of Outcome Ranking score at 10 weeks and monitoring for adverse events. Data will be analyzed using statistical methods to compare outcomes between the treatment groups. The total duration includes initial treatment and follow-up assessments up to 10 weeks, with ongoing oral therapy for one year.

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