Visceral Leishmaniasis in Asia

Pharmacovigilance study Phase IV

CTRI/2012/08/00289  |  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
• 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.

• ClinicalTrials.gov
• Results in PLOS NTDs (2017)
• DNDi project page

Evaluation of combination treatments Phase III

NCT00696969  |  India  |  Completed

Safety and efficacy study to evaluate different combination treatment regimens for visceral leishmaniasis (India).

• ClinicalTrials.gov
• Results in The Lancet (2011)
• DNDi project page

 

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.

• ClinicalTrials.gov
• DNDi project page

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.

• ClinicalTrials.gov
• Results in Clinical Infectious Diseases (2018)
• DNDi project page

Fexinidazole Phase II

NCT01980199 |  Sudan  |  Terminated

Trial to determine efficacy of fexinidazole in visceral leishmaniasis patients in Sudan.

• ClinicalTrials.gov
• DNDi project page

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).

• ClinicalTrials.gov
• Results in PLOS NTDs (2014)
• DNDi project page

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).

• ClinicalTrials.gov
• Results in PLOS NTDs (2017)
• DNDi project page

 

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.

• Clinical Trials Registry India 
• MSF project page
• DNDi project page

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.

• ClinicalTrials.gov
• DNDi project page

 

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.

• Clinical Trials Registry India
• DNDi project page

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.

• ClinicalTrials.gov
• DNDi project page

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.

• Clinical Trials Registry India

 

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.

• ClinicalTrials.gov
• DNDi project page

Imiquimod plus antimony immunochemotherapy Phase III

NCT00257530 |  Peru |  Completed

Imiquimod plus antimony immunochemotherapy for cutaneous leishmaniasis.

• ClinicalTrials.gov
• Results in PLOS NTDs (2009)
• DNDi project page

Topical amphotericin B cream Phase I/II

NCT01845727 |  Colombia  |  Completed

Topical 3% amphotericin B cream for the treatment of cutaneous leishmaniasis in Colombia (anfoleish).

• ClinicalTrials.gov
• DNDi project page

 

Last update: February 2018