- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04059770
Randomized Trial of Liposomal Amphotericin B for Histoplasmosis in AIDS Patients
Open Label Phase-II Randomized Trial of Three Liposomal Amphotericin B Regimens as Induction Therapy for Disseminated Histoplasmosis in AIDS Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a prospective randomized non-comparative multicenter open label trial of induction therapy with LAmB for DH in AIDS patients, followed by oral therapy with itraconazole.
The sample size planned is 99 patients of both sexes, older than 18 years (33 patients per study arm), infected with HIV and with confirmed diagnosis for DH. This sample size considers 10% of dropout.
The study will be conducted in accordance with the Helsinki Declaration, as well as the Standards national and international Guidelines for Good Clinical Practices.
Eight research centres in Brazil will competitively recruit patients: Santa Casa de Misericórdia de Porto Alegre (Porto Alegre; Dr Alessandro C. Pasqualotto), Hospital de Clínicas de Porto Alegre (Porto Alegre; Dr Diego R. Falci), Hospital Nossa Senhora da Conceição (Porto Alegre; Dr Marineide Melo), Hospital de Doenças Tropicais (Goiânia; Dr Cassia S. de Miranda Godoy), Hospital São José de Doenças Infecciosas (Fortaleza; Dr Terezinha M. J. Silva Leitão), and Hospital Giselda Trigueiro (Natal, Dr Monica B. Bay), Hospital Universitário Osvaldo Cruz (Recife, Dr. Filipe Prohaska Batista) e Instituto de Infectologia Emília Ribas (São Paulo, Dr. José Ernesto Vidal Bermudez).
AIDS patients with DH will be randomized to one of three study arms:
(i) single IV dose of 10 mg/kg of L-AmB; (ii) single IV dose of 10 mg/kg of L-AmB on day 1, followed by 5 mg/kg of L-AmB on day 3; (iii) IV dose of 3 mg/kg of L-AmB for 2 weeks.
Induction therapy will be followed in all patients by oral therapy with itraconazole capsules at 400 mg/daily for a year, azole drug which is already therapy of choice for consolidation of histoplasmosis, according to national and international Guidelines.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Alessandro C. Pasqualotto, MD PhD
- Phone Number: 55 51 999951614
- Email: acpasqualotto@hotmail.com
Study Contact Backup
- Name: Cássia Caurio
- Phone Number: 55 51 995888081
- Email: cassiacaurio@hotmail.com
Study Locations
-
-
Rio Grande Do Sul
-
Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090
- Irmandade Da Santa Casa de Misericordia de Porto Alegre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 with Itraconazole.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: single dose of L-AmB
single IV dose of 10 mg/kg of L-AmB on day 1;
|
(i) single IV dose of 10 mg/kg of L-AmB on day 1;
Other Names:
|
Experimental: 2 doses of L-AmB
IV dose of 10 mg/kg of L-AmB on day 1, followed by 5 mg/kg of L-AmB on day 3;
|
(ii) IV dose of 10 mg/kg of L-AmB on day 1, followed by 5 mg/kg of L-AmB on day 3;
Other Names:
|
Active Comparator: 2 weeks of L-AmB
IV dose of 3 mg/kg of L-AmB for 2 weeks.
|
(iii) IV dose of 3 mg/kg of L-AmB for 2 weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical response
Time Frame: day 14
|
Maximum daily temperature lower than 37.8 °C
|
day 14
|
Weight stability
Time Frame: day 14
|
This parameter will be measurement by a questionnaire, based on information about the patient weight in kilograms (Kg)
|
day 14
|
Blood Pressure
Time Frame: day 14
|
Analysis if any patient presented hypotension (systolic blood pressure ˂ 90 mm Hg)
|
day 14
|
Blood oxygen level
Time Frame: day 14
|
Normal arterial oxygen is approximately 75 to 100 millimeters of mercury (mm Hg).
Values under 60 mm Hg usually indicate the need for supplemental oxygen
|
day 14
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall mortality
Time Frame: day 14
|
Mortality rates attributed to the cause of death that is not directly and only related to histoplasmosis
|
day 14
|
Mortality due to histoplasmosis
Time Frame: day 14
|
Mortality rates attributed by the study investigator that are directly related to histoplasmosis
|
day 14
|
Renal function abnormalities
Time Frame: day 14
|
Microalbuminuria > 30 mg/24 h
|
day 14
|
Liver function abnormalities
Time Frame: day 14
|
Liver function abnormalities were serum levels of alanine and aspartate aminotransferase > 2.5 times normal or bilirubin levels > 2 times normal
|
day 14
|
Histoplasma urinary antigen concentrations
Time Frame: day 7, 14
|
Decrease of at least 50% in Histoplasma urinary antigen concentrations
|
day 7, 14
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Daiane Dalla Lana, PhD, Federal University of Health Science of Porto Alegre
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Three L-AmB Regimens in Histo
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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