# Use of DOOR and Win-Ratio Analysis in a Secondary Evaluation of a Histoplasmosis Clinical Trial

## TL;DR

This study used advanced statistical methods to compare two treatments for a fungal infection in HIV patients, finding no major differences and supporting future large trials.

## Contribution

The application of DOOR and Win-Ratio analyses to evaluate hierarchical composite endpoints in histoplasmosis treatment.

## Key findings

- No clear differences were observed between the two treatment regimens in terms of clinical desirability.
- The study supports the feasibility of simplified induction strategies for treating HIV-associated histoplasmosis.

## Abstract

Hierarchical composite end points may better reflect patient outcomes, rather than mortality alone. We applied DOOR and Win-Ratio analyses to a phase II trial comparing single high-dose vs standard liposomal amphotericin B for HIV-associated histoplasmosis. No clear differences were observed, supporting feasibility and informing design of future phase III trials.

Using DOOR and Win-Ratio methodologies to integrate mortality, toxicity, and rehospitalization into hierarchical composite endpoints, we compared single high-dose versus standard 14-day liposomal amphotericin B for HIV-associated disseminated histoplasmosis. The results demonstrated comparable overall clinical desirability between regimens, supporting the clinical viability of simplified induction strategies and paving the way for definitive phase III evaluation.