Visceral Leishmaniasis Clinical Trial
Official title:
A Prospective, Single Center, Open-Label, Dose-Escalation Phase II Study To Assess Safety and Efficacy Of Short-Course Regimens Of Amphotericin B Emulsion In Treatment Naïve Or Resistant Cases Of Visceral Leishmaniasis (Kala-Azar).
The purpose of this study is:
1. To evaluate the Safety and Efficacy of four different short-course regimens of
Amphotericin B emulsion in treatment of Kala-azar (visceral leishmaniasis) subjects who
are either treatment naive or treatment resistant to other antileishmanial drugs except
amphotericin B containing preparations.
2. To assess the safety and efficacy of single-bolus infusion of Amphotericin B emulsion
in treatment of Kala-azar.
1. To evaluate the Safety and Efficacy of four different short-course regimens of
Amphotericin B emulsion in treatment of Kala-azar (visceral leishmaniasis) subjects who
are either treatment naive or treatment resistant to other antileishmanial drugs except
amphotericin B containing preparations.
2. To assess the safety and efficacy of single-bolus infusion of Amphotericin B emulsion
in treatment of Kala-azar.
Subjects will be administered the study drug in either of the following four dose levels in
an ascending manner, starting with the first dosage regimen:
- 7.5 mg/kg on day 1 and day3 (Regimen 1)
- 10 mg/kg on day 1, followed by 5 mg/kg on day 3 (Regimen 2)
- 12.5 mg/kg on day 1, followed by 2.5 mg/kg on day 3 (Regimen 3)
- Single-bolus infusion of 15 mg/kg over 2-4 hours on day 1 (Regimen 4)
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT02839603 -
Asymptomatic Leishmania Infection in HIV Patients
|
||
| Completed |
NCT00370825 -
Combination Chemotherapy for the Treatment of Indian Kala-Azar
|
Phase 2 | |
| Recruiting |
NCT05426577 -
Evaluation of Less Invasive Procedures for Visceral Leishmaniasis Treatment Efficacy Monitoring Test of Cure
|
||
| Completed |
NCT01069198 -
A Community Trial for Visceral Leishmaniasis (VL)
|
N/A | |
| Completed |
NCT01032187 -
Amphotericin B to Treat Visceral Leishmaniasis in Brazilian Children
|
Phase 4 | |
| Completed |
NCT00371995 -
Short Course of Miltefosine and Liposomal Amphotericin B for Kala-azar
|
Phase 2 | |
| Completed |
NCT00604955 -
Expand Access/Assess Safety and Efficacy of Paromomycin IM Injection for the Treatment of Visceral Leishmaniasis
|
Phase 4 | |
| Completed |
NCT00342823 -
Immunogenetics of Visceral Leishmaniasis
|
N/A | |
| Completed |
NCT04003532 -
LAMP Assay for the Diagnosis of Visceral Leishmaniasis
|
||
| Terminated |
NCT01980199 -
Trial to Determine Efficacy of Fexinidazole in Visceral Leihmaniasis Patients in Sudan
|
Phase 2 | |
| Completed |
NCT00255567 -
Efficacy/Safety of Sodium Stibogluconate (SSG) Versus Paromomycin (PM) and SSG/PM Combination to Treat V Leishmaniasis
|
Phase 3 | |
| Not yet recruiting |
NCT06118749 -
Leishmania Antigen Rapid Diagnostic Test Proof-of-Concept and Validation Study
|
||
| Recruiting |
NCT04342715 -
A Study to Assess Immune Response Status in Patients Before and After Treatment for Visceral Leishmaniasis
|
||
| Completed |
NCT02431143 -
Pharmacokinetics/Safety of Miltefosine Allometric Dose for the Treatment of Visceral Leishmaniasis in Children in Eastern Africa
|
Phase 2 | |
| Completed |
NCT01122771 -
Phase III, Study of Three Short Course Combo (Ambisome®, Miltefosine, Paromomycin) Compared With AmBisome for the Treatment of VL in Bangladesh
|
Phase 3 | |
| Completed |
NCT03636659 -
Steady State Global Bioequivalence Study of Amphotericin B Liposome for Injection 50 mg/ Vial in Fed Condition
|
Phase 1 | |
| Not yet recruiting |
NCT01566552 -
Single Dose Liposomal Amphotericin B for Visceral Leishmaniasis
|
Phase 4 | |
| Completed |
NCT00696969 -
Safety and Efficacy Study to Evaluate Different Combination Treatment Regimens for Visceral Leishmaniasis
|
Phase 3 | |
| Completed |
NCT00318721 -
Efficacy, Acceptability and Cost-effectiveness of Long Lasting Insecticide Nets (LLIN) in the Prevention of Kala Azar
|
N/A | |
| Completed |
NCT00216346 -
Safety and Efficacy Study of Paromomycin to Treat Visceral Leishmaniasis
|
Phase 3 |