Single High Dose of Liposomal Amphotericin B in Human Immunodeficiency Virus/AIDS-Related Disseminated Histoplasmosis: A Randomized Trial.
Alessandro C Pasqualotto, Daiane Dalla Lana, Cassia S M Godoy...
https://pubmed.ncbi.nlm.nih.gov/37232940Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID05814432
Efficacy and Safety of High-dose Liposomal Amphotericin B (10 mg/kg) for Disseminated Histoplasmosis in AIDS: a Randomized Phase III Trial
Led by Federal University of Health Science of Porto Alegre · Updated on 2025-02-04
279
Participants Needed
5
Research Sites
13 weeks
Total Duration
On this page
Sponsors
F
Federal University of Health Science of Porto Alegre
Lead Sponsor
G
Gilead Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a single high dose (10 mg/kg) of liposomal amphotericin B compared to the standard two-week treatment (3 mg/kg daily) for treating disseminated histoplasmosis in adults with AIDS. This serious fungal infection commonly affects immunocompromised patients in endemic regions like Brazil. The study is a phase III randomized trial designed to test whether the single high dose is not worse than the standard therapy and to assess overall survival and other important outcomes. The study has two treatment groups: one receiving a single high dose of liposomal amphotericin B and the other receiving the standard treatment of liposomal amphotericin B daily for two weeks. After induction therapy, all participants will take oral itraconazole for one year. The trial includes careful safety monitoring by a Data Safety Monitoring Board, a steering committee, and a medical committee to ensure study quality and participant safety. The trial plans to enroll approximately 279 patients to achieve statistical goals. Participants will be closely followed with evaluations including survival rates at 14 days and 10 weeks, clinical response, fungal load reduction from urine and blood tests, and monitoring for adverse events. Data will be analyzed using various statistical methods to compare outcomes between the two groups. The total participation duration includes induction treatment and long-term oral therapy with follow-up assessments to monitor effectiveness and safety.
CONDITIONS
Brief Title
Efficacy and Safety of High-dose Liposomal Amphotericin B for Disseminated Histoplasmosis in AIDS
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adult patients admitted to participating centers
- Diagnosed with HIV infection regardless of antiretroviral therapy use
- Confirmed disseminated histoplasmosis by microscopy, culture, histopathology, or urinary antigen detection
- Patients with central nervous system infection may be included if an alternative CNS infection diagnosis is present
- Patients using fluconazole for oroesophageal candidiasis may be included
You will not qualify if you...
- Refusal to participate in the trial
- Previous diagnosis of histoplasmosis
- Pregnant or lactating women
- Patients with renal failure (serum creatinine > 2x upper limit of normal)
- Previous severe reaction to polyene antifungal
- Receipt of more than one dose of polyene antifungal in last 48 hours
- Suspected histoplasmosis involving central nervous system
- Patients expected to die within 48 hours after selection
- Concomitant diagnosis of cryptococcus or leishmaniasis under amphotericin treatment or prophylaxis
- Inability to take oral medication as judged by principal investigator of each center
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 2 weeks of induction therapy followed by 1 year of oral itraconazole
Participants receive induction therapy with liposomal amphotericin B either as a single high dose (10 mg/kg) or standard dose (3 mg/kg daily for two weeks). This is followed by oral itraconazole treatment for one year.
Daily visits for up to 2 weeks during induction therapy; follow-up visits as needed during oral itraconazole treatment
Follow-up
Duration - Up to 10 weeks post-induction therapy
Participants are monitored for clinical response, adverse events, fungal load reduction, and overall survival after treatment completion.
Visits on day 14 and week 10 for clinical assessments and safety evaluations
Trial Site Locations
Total: 5 locations
1
Hospital de Doenças Tropicais
Goiânia, Goiás, Brazil
Actively Recruiting
2
Hospital Giselda Trigueiro
Natal, Rio Grande do Norte, Brazil
Actively Recruiting
3
Federal University of Health Sciences of Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90050-170
Actively Recruiting
4
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Actively Recruiting
5
Hospital Geral de Roraima
Boa Vista, Roraima, Brazil
Actively Recruiting
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Research Team
A
Alessandro C Pasqualotto, MD PhD
D
Diego R Falci, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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