Randomized Trial of Liposomal Amphotericin B for Histoplasmosis in AIDS Patients
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|ClinicalTrials.gov Identifier: NCT04059770|
Recruitment Status : Recruiting
First Posted : August 16, 2019
Last Update Posted : July 16, 2021
|Condition or disease||Intervention/treatment||Phase|
|Histoplasmosis AIDS||Drug: single dose of L-AmB Drug: 2 doses of L-AmB Drug: 2 weeks of L-AmB||Phase 2|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||99 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open Label Phase-II Randomized Trial of Three Liposomal Amphotericin B Regimens as Induction Therapy for Disseminated Histoplasmosis in AIDS Patients|
|Actual Study Start Date :||February 14, 2020|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||March 2022|
Experimental: single dose of L-AmB
single IV dose of 10 mg/kg of L-AmB on day 1;
Drug: single dose of L-AmB
(i) single IV dose of 10 mg/kg of L-AmB on day 1;
Other Name: Intervention 1
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;
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;
Other Name: Intervention 2
Active Comparator: 2 weeks of L-AmB
IV dose of 3 mg/kg of L-AmB for 2 weeks.
Drug: 2 weeks of L-AmB
(iii) IV dose of 3 mg/kg of L-AmB for 2 weeks.
Other Name: Intervention 3
- Clinical response [ Time Frame: day 14 ]Maximum daily temperature lower than 37.8 °C
- Weight stability [ Time Frame: day 14 ]This parameter will be measurement by a questionnaire, based on information about the patient weight in kilograms (Kg)
- Blood Pressure [ Time Frame: day 14 ]Analysis if any patient presented hypotension (systolic blood pressure ˂ 90 mm Hg)
- 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
- Overall mortality [ Time Frame: day 14 ]Mortality rates attributed to the cause of death that is not directly and only related to histoplasmosis
- Mortality due to histoplasmosis [ Time Frame: day 14 ]Mortality rates attributed by the study investigator that are directly related to histoplasmosis
- Renal function abnormalities [ Time Frame: day 14 ]Microalbuminuria > 30 mg/24 h
- 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
- Histoplasma urinary antigen concentrations [ Time Frame: day 7, 14 ]Decrease of at least 50% in Histoplasma urinary antigen concentrations
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04059770
|Contact: Alessandro C. Pasqualotto, MD PhD||55 51 email@example.com|
|Contact: Cássia Caurio||55 51 firstname.lastname@example.org|
|Irmandade da Santa Casa de Misericórdia de Porto Alegre||Recruiting|
|Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090|
|Contact: Alessandro Pasqualotto, Dr|
|Study Chair:||Daiane Dalla Lana, PhD||Federal University of Health Science of Porto Alegre|