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Randomized Trial of Liposomal Amphotericin B for Histoplasmosis in AIDS Patients

NCT04059770 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2025-03-14

Study results available
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Summary

Disseminated histoplasmosis (DH) is one of the major AIDS-defining infections responsible for high mortality rates in HIV-infected patients. Liposomal amphotericin B (L-AmB) is considered the therapy of choice for AIDS-associated histoplasmosis.However, many patients in Latin America are still treated with high doses of deoxycholate amphotericin B (d-AmB) for long periods. These regimens are associated with toxicity and thus reduced efficacy. Therefore, a better treatment strategy is necessary to improve the activity of this amphotericin B treatment. Treatment with a high dose of L-AmB for short periods (rather than standard doses for longer periods) is a promising approach considering that the antifungal effect of amphotericin B depends on peak concentrations. This randomized open-label Phase II study aims to determinate and to compare the activity and safety of three L-AmB regimens, as induction therapy for DH in AIDS patients.

Conditions

  • Histoplasmosis
  • AIDS

Interventions

DRUG

single dose of L-AmB

(i) single IV dose of 10 mg/kg of L-AmB on day 1;

DRUG

2 doses of L-AmB

(ii) IV dose of 10 mg/kg of L-AmB on day 1, followed by 5 mg/kg of L-AmB on day 3;

DRUG

2 weeks of L-AmB

(iii) IV dose of 3 mg/kg of L-AmB for 2 weeks.

Sponsors & Collaborators

  • Hospital de Clinicas de Porto Alegre

    collaborator OTHER

  • Hospital Nossa Senhora da Conceicao

    collaborator OTHER

  • Irmandade Santa Casa de Misericórdia de Porto Alegre

    collaborator OTHER

  • Alessandro Pasqualotto

    lead OTHER

Principal Investigators

  • Daiane Dalla Lana, PhD · 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
2020-02-14
Primary Completion
2021-12-31
Completion
2022-03-30
FDA Drug
Yes

Countries

  • Brazil

Study Locations

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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 NCT04059770 on ClinicalTrials.gov