Visceral Leishmaniasis in Asia
Pharmacovigilance study Phase IV
CTRI/2012/08/002891 | India | Completed
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.
- Clinical Trials Registry India
- Results in PLOS NTDs (2018)
- Results in PLOS NTDs (2019)
- DNDi project page
Comparison combination regimens vs. AmBisome® Phase III
NCT01122771 | Bangladesh | Completed
Phase III, study of three short course combination regimens (Ambisome®, miltefosine, paromomycin) compared with AmBisome® for the treatment of visceral leishmaniasis in Bangladesh.
Evaluation of combination treatments Phase III
NCT00696969 | India | Completed
Safety and efficacy study to evaluate different combination treatment regimens for visceral leishmaniasis (India).
Visceral Leishmaniasis in Africa
Miltefosine/Paramomycin for treatment of primary VL in Eastern Africa Phase III
NCT03129646 | Ethiopia, Kenya, Sudan, Uganda
Clinical trial to compare the efficacy and safety of two combination regimens of Miltefosine and Paromomycin with the standard SSG-PM for the treatment of primary adult and children VL patients in Eastern Africa.
SSG vs PM vs SSG&PM Phase III
NCT00255567 | Ethiopia, Kenya, Sudan, Uganda | Completed
Efficacy/safety of sodium stibogluconate (SSG) versus paromomycin (PM) and SSG/PM combination to treat visceral leishmaniasis.
- ClinicalTrials.gov
- Results in PLOS NTDs (2012)
- Results in PLOS NTDs (2010)
- Results in PLOS NTDs (2010)
- DNDi project page
Miltefosine Phase II
NCT02431143 | Kenya, Uganda | Completed
Pharmacokinetics/Safety of miltefosine allometric dose for the treatment of visceral leishmaniasis in children in Eastern Africa.
Fexinidazole Phase II
NCT01980199 | Sudan | Terminated
Trial to determine efficacy of fexinidazole in visceral leishmaniasis patients in Sudan.
Ambisome Phase II
NCT00832208 | Ethiopia | Terminated
Open-label, sequential step, safety and efficacy study to determine the optimal single dose of Ambisome® for patients with visceral leishmaniasis (Ethiopia).
Evaluation of combination treatments Phase II
NCT01067443 | Kenya, Sudan | 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.
- ClinicalTrials.gov
- Results in Trials (2011)
- Results in PLOS NTDs (2016)
- Results in Journal of Antimicrobial Chemotherapy (2017)
- DNDi project page
Visceral Leishmaniasis in Latin America
Comparison of VL drugs Phase IV
NCT01310738 | Brazil | Completed
Efficacy and safety study of drugs for treatment of visceral leishmaniasis in Brazil (LVBrasil).
HIV/VL
New treatment for HIV/VL co-infection Phase III
CTRI/2015/05/005807 | India
A randomized trial of AmBisome® monotherapy and combination of AmBisome® and miltefosine for the treatment of Visceral Leishmanaisis in HIV positive patients in India. Study sponsored by MSF, with support from DNDi India.
Ambisome® / miltefosine Phase III
NCT02011958 | Ethiopia | Terminated
Efficacy trial of Ambisome® given alone and Ambisome® given in combination with miltefosine for the treatment of VL HIV positive Ethiopian patients.
PKDL
Short course regimens for treatment of PKDL in Asia Phase II
CTRI/2017/04/008421 | India, Bangladesh
Clinical trial testing both AmBisome® monotherapy and a combination of AmBisome® and miltefosine to assess the safety and efficacy for treatment of PKDL patients in the Indian Sub-continent.
Short course regimens for treatment of PKDL in Africa Phase II
NCT03399955 | Sudan
Clinical trial of two regimens to assess the safety and efficacy for treatment of PKDL patients in Sudan.
Follow-up study of PKDL in VL patients Phase IV
CTRI/2016/06/007020 | India | Completed
Cohort observational study to estimate the prevalence of post kala-azar dermal leishmaniasis (PKDL) in visceral leishmaniasis patients treated with three regimens in Bihar.
Cutaneous Leishmaniasis
Thermotherapy & miltefosine combination proof-of-concept Phase II
NCT02687971 | Colombia, Peru
Thermotherapy + a short course of miltefosine for the treatment of uncomplicated cutaneous leishmaniasis in the New World.
Imiquimod plus antimony immunochemotherapy Phase III
NCT00257530 | Peru | Completed
Imiquimod plus antimony immunochemotherapy for cutaneous leishmaniasis.
Topical amphotericin B cream Phase I/II
NCT01845727 | Colombia | Completed
Topical 3% amphotericin B cream for the treatment of cutaneous leishmaniasis in Colombia (anfoleish).
Last update: February 2018