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

NCT05814432 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 279

Last updated 2025-02-04

No results posted yet for this study

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).

Conditions

  • Disseminated Histoplasma Capsulatum Infection
  • AIDS and Infections
  • Immunosuppression
  • Fungal Infection

Interventions

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

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • Financiadora de Estudos e Projetos

    collaborator OTHER

  • Sociedade Gaucha de Infectologia

    collaborator UNKNOWN

  • Immuno-mycologics, Inc. (IMMY)

    collaborator UNKNOWN

  • Federal University of Health Science of Porto Alegre

    lead OTHER

Principal Investigators

  • Daiane F Dalla Lana, PhD · Federal University of Health Science of Porto Alegre

  • Renata B Ascenco Soares, PhD · HDT - SES/GO

  • Luana C Genz Bazana, PhD · Federal University of Health Science of Porto Alegre

  • Tarsila Vieceli, MD MSc · Federal University of Health Science of Porto Alegre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-16
Primary Completion
2026-08-28
Completion
2026-11-28
FDA Drug
Yes

Countries

  • Brazil

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05814432 on ClinicalTrials.gov