A Phase 4 interventional study of Antimoniate of N-methylglucamine and amphotericin B deoxycholate in Visceral Leishmaniasis, sponsored by University of Brasilia. Terminated at 5 sites in Brazil. Open to participants aged 6 Months to 50 Years. Per ClinicalTrials.gov, last updated 2017-09-05.
Sponsored by University of Brasilia · Phase 4, Interventional, and Treatment
This study is aimed to compare the efficacy and safety of medications currently used in Brazil for treatment of visceral leishmaniasis. The investigators will compare the effects of meglumine antimoniate, two formulations of amphotericin B: deoxycholate and liposomal, and a combination of meglumine plus the liposomal amphotericin B formulation. The study is designed to demonstrate the difference in efficacy measured as cure rate at six months after treatment and the safety profile based on the adverse event rate observed with each intervention.
Visceral leishmaniasis is a relevant public health problem in Brazil with approximately 3500 cases registered every year. Eight percent lethality rate has been observed during the past decade in spite of free of charge availability of antileishmanial drugs supplied by the public health system.
The present study was designed as a phase IV, multicentric, open label, active controlled clinical trial targeted to visceral leishmaniasis adult and pediatric cases.
The current drugs approved for visceral leishmaniasis treatment in Brazil will be compared in four treatment groups: meglumine antimoniate, amphotericin B deoxycholate, liposomal amphotericin B and a combination of single dose of liposomal amphotericin B plus meglumine antimoniate. Meglumine antimoniate treated patients will constitute the active control group.
Drugs will be compared based on the cure rate observed after six months follow-up.
The study arm submitted to treatment with Amphotericin B deoxycholate was suspended in September 2012.
185 studies on the registry are indexed under Leishmaniasis; 15 are open to participants now.
This study's enrollment of 378 is above the median of 80 across 133 interventional studies indexed under Leishmaniasis.
Browse Leishmaniasis studies →University of Brasilia is the lead sponsor of 63 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Antimoniate of N-methylglucamine 20mg/kg/d, I.V. for 20 consecutive days.
Drug: Antimoniate of N-methylglucamine
Liposomal amphotericin B 3mg/kg/d I.V. for 7 consecutive days.
Drug: Liposomal amphotericin B
Amphotericin B deoxycholate 1mg/kg/d I.V. for 14 consecutive days. This arm was suspended in September 19th, 2012, because of a relevant excess of adverse events and serious adverse events associated with this experimental intervention in comparison with the active comparator and the other two experimental arms. The suspension of this study arm was supported by a DSMB statement.
Drug: amphotericin B deoxycholate
Liposomal amphotericin B 10mg/kg/d, I.V. single dose on day 0 plus Antimoniate of N-methylglucamine 20mg/kg/d for 10 consecutive days on days 1 to 10.
Drug: Liposomal amphotericin B · Drug: Antimoniate of N-methylglucamine
Antimoniate of N-methyl glucamine 20mg/kg/d of pentavalent antimonial, I.V. for 20 consecutive days.
Also known as: Glucantime
1mg/kg/d, I.V. for 14 consecutive days.
Also known as: Fungizone, Anforicin B
3mg/kg/d, I.V. for 7 consecutive days.
Also known as: AmBisome
10mg/kg/d, I.V. single dose.
Also known as: AmBisome
20mg/kg/d of pentavalent antimonial I.V. for 10 days
Also known as: Glucantime
Cure rate
Complete remission of clinical signs and symptoms, three months after treatment plus normal hematological lab evaluation and no relapse at sixth month follow-up.
Time frame: 6 month
Improvement rate
Fever disappearing, stable or improving hematological lab abnormalities plus any spleen size reduction.
Time frame: 30 days
Relapse rate
Reappearing of signs and symptoms after any improvement observed after treatment, during the six months follow-up period.
Time frame: (6 months post treatment) After treatment until the sixth month of follow-up
Serious adverse events rate
Rate of adverse events defined as conditions which fulfilled any of the following: results in death, is life threatening, requires inpatient hospitalization or prolongs hospitalization, results in persistent or significant disability/incapacity, causes a congenital anomaly or birth defect or it is considered as a important medical event for the responsible clinician.
Time frame: During (day one) and within the six months follow-up
Adverse event rate and intensity
Cumulative rate of any adverse event, including clinical, laboratory and electrocardiographic abnormalities observed within the treatment and follow-up periods. All adverse events will be graded using an adapted ACTG 0-4 scale.
Time frame: During (day one) treatment and within the six months follow-up
Plan to share: Undecided
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University of Brasilia