Randomized Trial of Liposomal Amphotericin B for Histoplasmosis in AIDS Patients (NCT04059770) | Clinical Trial Compass
CompletedPhase 2
Randomized Trial of Liposomal Amphotericin B for Histoplasmosis in AIDS Patients
Brazil118 participantsStarted 2020-02-14
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult (\> 18 years) HIV-infected hospitalized patients diagnosed with HD by the means of (i) urine Histoplasma positive antigen (IMMY® monoclonal antibody test); (ii) confirmation by classical mycological methods (microscopy, culture or histopathology); or (iii) Histoplasma positive qualitative polymerase chain reaction (PCR) in bronchoalveolar lavage samples, bone marrow aspirates or tissue samples.
* Patients will be included despite of the use of antiretroviral therapy (ART).
* Understanding and signed the Informed Consent Form.
Exclusion Criteria:
* Patients with previous diagnosis of histoplasmosis.
* Pregnant or lactating women.
* Patients with renal insufficiency (serum creatinine and urea \> 1.5x the upper limit of normal).
* Abnormal aminotransferases (up to \> 3x the upper limit of normal) and patients with a severe prior reaction to polyene antifungal.
* Patients who have received more than one dose of a polyene antifungal in the last 48 hours.
* Patients who refuse to participate in the study.
* Patients diagnosed with histoplasmosis that affect the central nervous system.
* Patients who, at the trial of the attending physician, are expected to die within 48 hours.
* Patients diagnosed with tuberculosis.
* Patients with any disease or condition that, in the opinion of the investigator, may interfere with the assessments or participation in the study.
* Patients receiving drugs that cause significant (relative or absolute) drug interaction …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.