High-dose Liposomal Amphotericin B for treating disseminated histoplasmosis in AIDS patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase III trial evaluates the safety and efficacy of a single high dose of liposomal amphotericin B (10 mg/kg) compared to the standard therapy dose (3 mg/kg for two weeks) in patients with disseminated histoplasmosis associated with AIDS. The study aims to determine non-inferiority in terms of two-week mortality and superiority in a Desirability of Outcome Ranking (DOOR). It includes adult patients diagnosed with disseminated histoplasmosis, confirmed through various mycological methods. The trial will also establish a Data Safety Monitoring Board to oversee participant safety and efficacy throughout the study duration.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult patients admitted to the centers that will be part of the study
* Infected by the HIV, regardless of the use of antiretroviral therapy
* Patients diagnosed with disseminated histoplasmosis, confirmed by classical mycological methods (microscopy, culture or histopathology) or urinary Histoplasma antigen detection
* Patients with central nervous system (CNS) infection may be included if they have an alternative diagnosis suggestive of another CNS infection
* Patients using fluconazole for oroesophageal candidiasis may be included

Exclusion criteria:

* Refusal to participate in the trial
* Previous diagnosis of histoplasmosis
* Pregnant or lactating women
* Patients with renal failure at any given time (serum creatinine \> 2x or upper limit of normality (KDIGO, 2012)
* Previous severe reaction to a polyene antifungal
* Receipt of more than one dose of a polyene antifungal in the last 48 h
* Suspected histoplasmosis involving the central nervous system
* Patients who, in the judgment of the attending physician, have the prospect of death within the next 48 hours after selection, will also be excluded
* Patients with suspected histoplasmosis involving the central nervous system (CNS), as this condition requires high doses of amphotericin B
* Patients with the prospect of death in the next 48 hours after selection
* Patients with a concomitant diagnosis of cryptococcus will be excluded, as will patients with leishmaniasis in treatment or in secondary prophylaxis with amphotericin
* Patients without the capacity to administer enteral medication-at the discretion of the principal investigator of each center-considering that these patients will not be able to use itraconazole orally or through a feeding tube

Where it's running

• Hospital de Doenças Tropicais
  Goiânia, Goiás, Brazil Recruiting
• Hospital Giselda Trigueiro
  Natal, Rio Grande do Norte, Brazil Recruiting
• Federal University of Health Sciences of Porto Alegre
  Porto Alegre, Rio Grande do Sul, Brazil Recruiting
• Hospital de Clinicas de Porto Alegre
  Porto Alegre, Rio Grande do Sul, Brazil Recruiting
• Hospital Geral de Roraima
  Boa Vista, Roraima, Brazil Recruiting

Study contacts

• Study coordinator: Alessandro C Pasqualotto, MD PhD
• Email: acpasqualotto@hotmail.com
• Phone: +5551999951614

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Thymalfasin added to standard care for adults with sepsis and immune dysfunction

  This study tests whether thymosin alpha-1 helps restore immune function in adults with sepsis who have weakened immunity.

  Recruiting Shanghai Zhongshan Hospital · Shanghai, Shanghai Municipality · NCT07866118

• FUNGAL-P: A score to spot fungal pneumonia early in adults with pneumonia

  Aimed at adults with pneumonia, this study tests a new score to help identify fungal pneumonia sooner so doctors can test appropriately and start antifungal treatment when needed.

  Recruiting Azienda Ospedaliero-Universitaria Careggi · Florence · NCT07681583

• Metabolic and Functional Study of γδ T Cells in Critically Ill Patients

  Researchers will look at how γδ T cells behave in severely ill patients, including those with sepsis, to see how their metabolism and function change.

  Recruiting Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Outside of the US · NCT07680816

• Using FibroScan to guide lowering immune-suppressing drugs after liver transplant

  This will test whether using FibroScan to measure liver stiffness lets doctors safely reduce immunosuppressive drugs in adults at least 2 years after a liver transplant who don't have autoimmune liver disease or recent rejection.

  Recruiting University of Alberta · Edmonton, Alberta · NCT07206277

• Preemptive genetic testing to guide tacrolimus treatment for kidney transplant patients

  This study will test whether doing a genetic test before transplant to guide tacrolimus dosing helps people on the kidney transplant waiting list stay safer and use health resources more efficiently.

  Recruiting Phase 4 Instituto de Investigación Hospital Universitario La Paz · Madrid, Madrid · NCT06701825

• Pharmacogenomics to improve voriconazole dosing for fungal infections

  This trial will test whether using a patient's CYP2C19 genotype with Bayesian dosing software helps get voriconazole levels into the therapeutic range by Day 8 for people with fungal infections, including those with blood cancers.

  Recruiting at 7 sites Phase 2 The University of Queensland · Seattle, Washington and 6 other locations · NCT06510699

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.