Leishmaniasis

Visceral Leishmaniasis in Asia

Pharmacovigilence study – CTRI/2012/08/002891
A pilot project to evaluate the safety and effectiveness of new treatment modalities for the management of visceral leishmaniasis in the endemic regions of India.
puce Clinical Trials Registry India

Comparison combination regimens vs. AmBisome®NCT01122771 [Completed]
Phase III, study of three short course combination regimens (Ambisome®, miltefosine, paromomycin) compared with AmBisome® for the treatment of visceral leishmaniasis in Bangladesh.
puce ClinicalTrials.gov

Evaluation of combination treatments – NCT00696969 [Completed]
Safety and efficacy study to evaluate different combination treatment regimens for visceral leishmaniasis (India).
puce ClinicalTrials.gov
puce Results in The Lancet (2011)

 

Visceral Leishmaniasis in Africa

Miltefosine – NCT02431143 [Completed]
Pharmacokinetics/Safety of Miltefosine allometric dose for the treatment of visceral leishmaniasis in children in Eastern Africa
.
puce ClinicalTrials.gov

Fexinidazole – NCT01980199 [Terminated]
Trial to determine efficacy of fexinidazole in visceral leishmaniasis patients in Sudan.
puce
ClinicalTrials.gov

Ambisome – NCT00832208 [Terminated]
Open-label, sequential step, safety and efficacy study to determine the optimal single dose of Ambisome® for patients With visceral leishmaniasis (Ethiopia).
puce ClinicalTrials.gov
puce Results in PLOS NTDs (2014)

Evaluation of combination treatments – NCT01067443 [Completed]
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.
puce ClinicalTrials.gov
puce Results in Trials (2011)
puce
Results in PLOS NTDs (2016)

SSG vs PM vs SSG&PM – NCT00255567 [Completed]
Efficacy/safety of sodium stibogluconate (SSG) versus paromomycin (PM) and SSG/PM combination to treat visceral leishmaniasis (Ethiopia, Kenya, Sudan, Uganda).
puce ClinicalTrials.gov
puce Results in PLOS NTDs (2012)
puce Results in PLOS NTDs (2010)

puce Results in PLOS NTDs (2010)

 

Visceral Leishmaniasis in Latin America

Comparison of VL drugs – NCT01310738 [Terminated]
Efficacy and safety study of drugs for treatment of visceral leishmaniasis in Brazil (LVBrasil).
puce ClinicalTrials.gov

 

HIV/VL

Pentamidine – NCT01360762 [Completed]
Prophylaxis of visceral leishmaniasis relapses in HIV co-infected patients with pentamidine: a cohort study.
puce
ClinicalTrials.gov
puce
Results in PLOS NTDs (2015)

Ambisome® / miltefosine- NCT02011958
Efficacy trial of Ambisome® given alone and Ambisome® given in combination with miltefosine for the treatment of VL HIV positive Ethiopian patients.
puce
ClinicalTrials.gov

Pentamidine – NCT01360762 [Completed]
Prophylaxis of visceral leishmaniasis relapses in HIV co-infected patients with pentamidine: a cohort study.
puce
ClinicalTrials.gov

 

PKDL

PKDL – Follow-up study
Cohort observational study to estimate the prevalence of post kala-azar dermal leishmaniasis (PKDL) in visceral leishmaniasis patients treated with three regimens in Bihar.
puce
Clinical Trials Registry India

 

Cutaneous Leishmaniasis

Thermotherapy & miltefosine combination – NCT02687971 [Completed]
Thermotherapy + a short course of miltefosine for the treatment of uncomplicated cutaneous leishmaniasis in the New World.
puce
ClinicalTrials.gov 

Topical amphotericin B cream – NCT01845727
Topical 3% amphotericin B cream for the treatment of cutaneous leishmaniasis in Colombia (anfoleish).
puce ClinicalTrials.gov

Imiquimod plus antimony immunochemotherapy – NCT00257530 [Completed]
Imiquimod plus antimony immunochemotherapy for cutaneous leishmaniasis.
puce ClinicalTrials.gov
puce Results in PLOS NTDs (2009)