Clinical trials: Visceral Leishmaniasis
Visceral Leishmaniasis
Miltefosine/Paromomycin Phase III Trial for Treatment of Primary Visceral Leishmaniasis (VL) Patients in Eastern Africa
This is an open label, Phase III, randomized, controlled, parallel arm multicentre non-inferiority clinical trial to compare the efficacy and safety of two combination regimens of Miltefosine and Paromomycin with the standard…
- Trial name
- NCT03129646
- Testing
- Miltefosine, Paromomycin, Sodium stibogluconate
- Where
- 7 sites in Ethiopia, Kenya and 2 more
- Volunteers
- 439 people
- Sponsor
- Drugs for Neglected Diseases
Visceral Leishmaniosis, HIV-infection/Aids
Prophylaxis of Visceral Leishmaniasis Relapses in HIV Co-infected Patients With Pentamidine: a Cohort Study
Visceral leishmaniosis (VL) is widely reported in Ethiopia, with about 30% of cases being associated with human immunodeficiency virus (HIV).
- Trial name
- NCT01360762
- Testing
- Pentamidine
- Where
- 3 sites in Ethiopia
- Volunteers
- 74 people
- Sponsor
- Institute of Tropical Medicine, Belgium
Post-kala-azar Dermal Leishmaniasis
Safety and Effectiveness of Short-course AmBisome in the Treatment of PKDL in Bangladesh
The safety and effectiveness of AmBisome 15 mg/kg, given over 15 days in 5 biweekly infusions of 3 mg/kg on an outpatient basis, is evaluated in clinically diagnosed PKDL patients of 12 years and older in a highly endemic area in…
- Trial name
- NCT03311607
- Testing
- AmBisome
- Volunteers
- 280 people
- Sponsor
- Medecins Sans Frontieres, Netherlands
Visceral Leishmaniasis
Steady State Global Bioequivalence Study of Amphotericin B Liposome for Injection 50 mg/ Vial in Fed Condition
The primary objective is to determine clinical bioequivalence of Amphotericin B liposome for injection of Auromedics Pharma LLC, USA and AmBisome (Amphotericin B) liposome for injection of Astellas Pharma US, Inc., in patients…
- Trial name
- NCT03636659
- Testing
- Amphotericin B Liposome, AmBisome (Amphotericin B) Liposome
- Where
- 3 sites in Bangladesh, India
- Volunteers
- 140 people
- Sponsor
- Aurobindo Pharma Ltd
Primary Visceral Leishmaniasis
LXE408 for Treatment of Visceral Leishmaniasis in Ethiopia, a Proof of Concept Study
This is a randomized, open-label, phase II, single-centre study, with one LXE408 regimen and one calibrator arm with the standard of care SSG combined with PM, to be conducted in male and female adult (≥18 years and <45 years)…
- Trial name
- NCT05957978
- Testing
- LXE408, sodium stibogluconate, Paromomycin
- Where
- Ethiopia
- Volunteers
- 52 people
- Sponsor
- Drugs for Neglected Diseases
Visceral Leishmaniasis
Trial to Determine Efficacy of Fexinidazole in Visceral Leihmaniasis Patients in Sudan
This study is designed to determine the efficacy of Fexinidazole as an oral treatment in Visceral Leishmanisasis sudanese adults patients.
- Trial name
- NCT01980199
- Testing
- Fexinidazole
- Where
- Sudan
- Volunteers
- 14 people
- Sponsor
- Drugs for Neglected Diseases
Leishmaniasis, Leishmaniasis, Visceral
Clinical Investigation of Infections Due to Leishmanial Parasites
Mechanisms of host immune response to intracellular protozoa will be investigated in patients with naturally acquired infection employing a variety of in-vitro techniques.
- Trial name
- NCT00001169
- Where
- United States
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Visceral Leishmaniasis
Immunogenetics of Visceral Leishmaniasis
Visceral leishmaniasis is a potentially fatal disease caused in South America by the protozoan Leishmania chagasi. In neighborhoods with high exposure rates, the outcome of human infection with L.
- Trial name
- NCT00342823
- Where
- Brazil
- Volunteers
- 7,000 people, healthy volunteers welcome
- Sponsor
- National Human Genome Research Institute (NHGRI)
Visceral Leishmaniasis
Efficacy Trial of Ambisome Given Alone and Ambisome Given in Combination With Miltefosine for the Treatment of VL HIV Positive Ethiopian Patients.
The overall objective of this trial is to identify a safe and effective treatment for visceral leishmaniasis (VL) in HIV co-infected Ethiopian patients.
- Trial name
- NCT02011958
- Testing
- Liposomal Amphotericin B, Miltefosine
- Where
- 2 sites in Ethiopia
- Volunteers
- 59 people
- Sponsor
- Drugs for Neglected Diseases
Visceral Leishmaniasis
Safety and Efficacy Study of Paromomycin to Treat Visceral Leishmaniasis
Symptomatic Visceral Leishmaniasis(VL)is fatal; Due to the increasing resistance to standard therapy with antimonials, there is a need for new safe, efficacious, low-cost therapies for the treatment of VL.
- Trial name
- NCT00216346
- Testing
- Paromomycin sulfate, Amphotericin B
- Where
- 4 sites in India
- Volunteers
- 667 people
- Sponsor
- PATH
Visceral Leishmaniasis
Efficacy and Safety Study of Drugs for Treatment of Visceral Leishmaniasis in Brazil
This study is aimed to compare the efficacy and safety of medications currently used in Brazil for treatment of visceral leishmaniasis.
- Trial name
- LVBrasil (NCT01310738)
- Testing
- Antimoniate of N-methylglucamine, amphotericin B deoxycholate, Liposomal amphotericin B
- Where
- 5 sites in Brazil
- Volunteers
- 378 people
- Sponsor
- University of Brasilia
Visceral Leishmaniasis
LAMP Assay for the Diagnosis of Visceral Leishmaniasis
This study will evaluate the of the loop-mediated amplification assay (LAMP) as a diagnostic as well as a Test-of-Cure (ToC) for visceral leishmaniasis (VL) in an endemic area in Ethiopia.
- Trial name
- EvaLAMP (NCT04003532)
- Where
- Ethiopia
- Volunteers
- 500 people
- Sponsor
- Prof. Dawit Wolday
Visceral Leishmaniasis
Amphotericin B Treatment in Visceral Leishmaniasis
This study is being conducted to assess the safety and efficacy of amphotericin B deoxycholate in doses of 0.75 mg/kg or 1.0 mg/kg for 15 doses.
- Trial name
- NCT00310505
- Testing
- Amphotericin B deoxycholate given as daily administration
- Where
- India
- Volunteers
- 1,500 people
- Sponsor
- Banaras Hindu University
Leishmaniasis, Visceral
Evaluation of Antibody Detection Tests for Visceral Leishmaniasis Diagnosis in Eastern Africa
According to recent estimates by the World Health Organization (WHO) on eastern Africa, not all visceral leishmaniasis (VL) cases reported are confirmed by a laboratory test, probably due to limited access to accurate diagnostic…
- Trial name
- VL-DX-EAFR (NCT03646981)
- Testing
- Leishmania Ab Rapid Test (CTK, Biotech)
- Where
- 2 sites in Ethiopia, Kenya
- Volunteers
- 704 people
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
Invasive Fungal Infections, Neutropenic Fever
Human Bioequivalence Study of Liposomal Amphotericin B for Injection
A single-center, randomized, open-label, single-dose, two-period, double-crossover study to evaluate the bioequivalence of liposomal amphotericin B for injection (test product) manufactured by Sichuan Huiyu Pharmaceutical Co.…
- Conditions
- Invasive Fungal Infections, Neutropenic Fever, Visceral Leishmaniasis
- Trial name
- NCT06983665
- Testing
- Test product (Liposomal amphotericin B for injection, Sichuan Huiyu Pharmaceutical Co., Ltd.), Reference product (AmBisome®, Astellas Pharma US Inc.)
- Where
- China
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Sichuan Huiyu Pharmaceutical Co., Ltd
Visceral Leishmaniasis
Phase III, Study of Three Short Course Combo (Ambisome®, Miltefosine, Paromomycin) Compared With AmBisome for the Treatment of VL in Bangladesh
This protocol will evaluate the efficacy and safety of various combinations of the three drugs; AmBisome, Paromomycin and Miltefosine at reduced total dosage against the standard treatment with a total dose of 15mg/kg of AmBisome.
- Trial name
- NCT01122771
- Testing
- Liposomal amphotericin B, liposomal amphotericin B + miltefosine, liposomal amphotericin B + paromomycin
- Where
- 4 sites in Bangladesh
- Volunteers
- 602 people
- Sponsor
- Drugs for Neglected Diseases
Visceral Leishmaniasis
Pharmacokinetics/Safety of Miltefosine Allometric Dose for the Treatment of Visceral Leishmaniasis in Children in Eastern Africa
This is a multicenter, non-comparative, open-label clinical trial to assess the Pharmacokinetics (PK) and safety of miltefosine using an allometric dose algorithm in the treatment of children with primary Visceral Leishmaniasis…
- Trial name
- NCT02431143
- Testing
- Miltefosine
- Where
- 2 sites in Kenya, Uganda
- Volunteers
- 30 people
- Sponsor
- Drugs for Neglected Diseases
Leishmaniasis, Cutaneous, Leishmaniasis
Ex Vivo Immunogenicity Screening of Vaccine Candidate Antigen Combinations in Ethiopian Patients With Leishmaniasis
This study assesses the immunoprevalence (presence of the induced T-cell response across different patients (and thus HLA types) of six prioritized IPX-derived Leishmania antigens, using Good Laboratory Practice-grade soluble…
- Conditions
- Leishmaniasis, Cutaneous, Leishmaniasis, Leishmaniasis, Visceral, Immunogenicity
- Trial name
- LEISHVAC (NCT07783243)
- Where
- 2 sites in Ethiopia
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Institute of Tropical Medicine, Belgium
Primary Visceral Leishmaniasis
Clinical Trial to Assess the Safety and Efficacy of Sodium Stibogluconate (SSG) and AmBisome® Combination, Miltefosine and AmBisome® and Miltefosine Alone for the Treatment Visceral Leishmaniasis in Eastern Africa
This study is to assess if shorter combinations of SSG plus single dose AmBisome®, Miltefosine plus single dose AmBisome® and Miltefosine alone are effective in treating visceral leishmaniasis in Eastern Africa.
- Trial name
- NCT01067443
- Testing
- Liposomal amphotericin B (AmBisome®) and sodium stibogluconate, Liposomal amphotericin B + miltefosine, Miltefosine
- Where
- 3 sites in Kenya, Sudan
- Volunteers
- 151 people
- Sponsor
- Drugs for Neglected Diseases
Leishmaniasis, Visceral
To Study the Effect Of Single Infusions Of Amphotericin B Lipid Preparations in Treatment of Patients Of Kala Azar
The purpose of this study is to determine whether a single bolus of dose of Amphoterin B lipid emulsion (Amphomul) is as efficacious and safe compared to a single dose Liposomal Amphotericin B in treating patients with Indian…
- Trial name
- NCT00876824
- Testing
- Amphotericin B Lipid emulsion, Liposomal Amphotericin B
- Where
- 4 sites in India
- Volunteers
- 500 people
- Sponsor
- Bharat Serums and Vaccines Limited