SCYX-7158

Oxaborole SCYX-7158 – NCT01533961 [Completed]
Human African trypanosomiasis: first-in-man clinical trial of a new medicinal product, SCYX-7158.
puce ClinicalTrials.gov

 

Fexinidazole

Fexinidazole – NCT03025789
An open-label study assessing effectiveness,safety and compliance with fexinidazole in patients with human African trypanosomiasis due to T.b. Gambiense at any stage
puce ClinicalTrials.gov

Fexinidazole – Bioequivalence study – NCT02571062 [Completed]
Bioequivalence Study – Reference clinical fexinidazole tablet versus proposed market formulation.
puce
ClinicalTrials.gov

Fexinidazole – NCT02184689
Efficacy and safety of fexinidazole in children at least 6 years old and weighing over 20 kg with human African trypanosomiasis (HAT) due to T.b. Gambiense: a prospective, multicentre, open study, plug-in to the Pivotal Study.
puce ClinicalTrials.gov

Fexinidazole – NCT02169557
Efficacy and safety of fexinidazole in patients with stage 1 or early stage 2 human African trypanosomiasis (HAT) due to T.b. Gambiense: a prospective, multicentre, open-label cohort study, plug-in to the Pivotal Study.
puce ClinicalTrials.gov

Fexinidazole – NCT01340157 [Completed]
Fexinidazole (1200mg) bioavailability under different food intake conditions.
puce ClinicalTrials.gov

Fexinidazole – NCT01685827
Pivotal Study of fexinidazole for human African trypanosomiasis in stage 2 (Phase II-III).
puce ClinicalTrials.gov

Fexinidazole – NCT01483170 [Terminated]
Multiple dose study to evaluate security, tolerance and pharmacokinetic of fexinidazole (drug candidate for human African trypanosomiasis) administered with a loading dose and with food.
puce ClinicalTrials.gov

Fexinidazole – NCT00982904 [Completed]
Human African trypanosomiasis: first-in-man clinical trial of a new medicinal product, fexinidazole.
puce ClinicalTrials.gov
puce Results in Clinical Pharmacokinetics (2014)

 

NECT

NECT-FIELD study – NCT00906880 [Completed]
Clinical study to assess the tolerability, feasibility and effectiveness of nifurtimox and eflornithine (NECT) for the treatment of T.b. Gambiense human African trypanosomiasis (HAT) in the meningo-encephalitic phase (NECT-FIELD).
puce ClinicalTrials.gov
puce Results in PLOS NTDs (2012)

Eflornithine-nifurtimox combination – NCT00146627 [Completed]
Efficacy – Clinical study comparing the nifurtimox-eflornithine combination with the standard eflornithine regimen for the treatment of T.b. Gambiense human African trypanosomiasis in the meningoencephalitic phase.
puce ClinicalTrials.gov
puce Results in The Lancet (2009)

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)

Fexinidazole – NCT02498782
Study to evaluate fexinidazole dosing regimens for the treatment of adult patients with Chagas disease.
puce
ClinicalTrials.gov

Parasitological response assessment – NCT01678599
Optimization of PCR technique to assess parasitological response for patients with chronic Chagas disease (PCR).
puce ClinicalTrials.gov

Paediatric benznidazole – NCT01549236
Population pharmacokinetics study of benznidazole in children with Chagas disease (pop PK Chagas).
puce ClinicalTrials.gov

E1224 – NCT01489228 [Completed]
Proof-of-concept study of E1224 to treat adult patients with Chagas disease.
puce ClinicalTrials.gov

LIVING Study – NCT02346487
Prospective study of lopinavir based ART for HIV infected children globally (LIVING Study).
puce
ClinicalTrials.gov

Ritonavir superboosting study for TB/HIV – NCT02348177
Pharmacokinetics of lopinavir/ritonavir superboosting in Infants and young children co-infected with HIV and TB.
puce
ClinicalTrials.gov
puce
Results on the CROI 2017 Conference Website (2017)

Emodepside – BAY 44-4400
First-in-man clinical trial of emodepside (BAY 44-4400).
puce ClinicalTrials.gov

Sofosbuvir/Ravidasvir Combination Therapy NCT02961426 [Recruiting]

This is a multicentre, multi-country, trial to assess the efficacy, safety, tolerance, and pharmacokinetics of sofosbuvir plus ravidasvir for the treatment of HCV infection.
– Malaysia, Thailand
– Phase II/III

puce ClinicalTrials.gov

puce DNDi project page

 

ASAQ

Liberia – Tolerability – ISRCTN40020296 [Completed]
A phase IV randomised study to assess the tolerability of artesunate-amodiaquine (AS-AQ) (Winthrop® fixed dose combination [FDC]) and artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in Liberia.
puce Current Controlled Trials
puce Results in Malaria Journal (2013)

Liberia – Efficacy – ISRCTN51688713 [Completed]
Efficacy of amodiaquine-artesunate and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Nimba county, Liberia.
puce Current Controlled Trials
puce Results in Malaria Journal (2013)

India – ISRCTN84408319 [Completed]
Multicentre, open-label randomised clinical trial of efficacy and tolerability of the fixed-dose artesunate/amodiaquine (AS/AQ) combination therapy and amodiaquine (AQ) monotherapy for treatment of uncomplicated falciparum malaria in India.
puce Current Controlled Trials
puce Results in Malaria Journal (2012)

Burkina Faso – ISRCTN07576538 [Completed]
A randomised, controlled, open-label, parallel-group study comparing the efficacy and safety of an oral artesunate-amodiaquine fixed-dose combination therapy over 3 subsequent days to an equivalent dose regimen of the individual drugs for the treatment of children with Plasmodium falciparum.
puce Current Controlled Trials
puce Results in Malaria Journal (2009)
puce Results in Malaria Journal (2009)

Kenya – ISRCTN16409445 [Completed]
Open-label randomised clinical trial of pharmacokinetics, efficacy, and tolerability of the fixed-dose artesunate/amodiaquine combination therapy versus both drugs administered separately for treatment of uncomplicated falciparum malaria in Kenya.
puce Current Controlled Trials
puce Results in Malaria Journal (2014)
puce Results in Antimicrobial Agents and Chemotherapy (2010)

Africa – ATAQ EASY – NCT00316329 [Completed]
To demonstrate the non-inferiority, in terms of clinical and parasitological efficacy on D28 of administration of Coarsucam™ (artesunate+amodiaquine fixed-dose combination), as a single daily dose, in comparison with administration of Coartem® (artemether+lumefantrine).
puce ClinicalTrials.gov
puce Results in Malaria Journal (2009)

ASAQ HNV – ISRCTN70132716 [Completed]
Artesunate and Amodiaquine: tolerability and pharmacokinetic study in healthy normal volunteers of non-fixed and fixed combination in Malaysia.
puce Current Controlled Trials
puce Results in European Journal of Clinical Pharmacology (2009)

 

 

ASMQ

Africa ISRCTN17472707 & PACTR201202000278282 [Completed]
A multicentre, open-label, prospective, randomised, controlled, phase IV study in Africa, assessing efficacy, safety and pharmacokinetics of ASMQ FDC in 940 children with uncomplicated Plasmodium falciparum malaria from Tanzania, Burkina Faso and Kenya versus artemether-lumefantrine.
puce Current Controlled Trials
puce
Pan African Clinical Trials Registry
puce Results in Lancet Infectious Diseases (2016)

India – ISRCTN70618692 [Completed]
Assessment of efficacy, safety and population-pharmacokinetics of the fixed-dose combination of artesunate-mefloquine in the treatment of acute uncomplicated Plasmodium falciparum malaria in India.
puce Current Controlled Trials
puce Results in Malaria Journal (2014)
puce Results in Journal of Vector Borne Diseases (2013)

HNV – ISRCTN22508774 [Completed]
A single dose two-phase crossover study to assess the tolerability and pharmacokinetic parameters of a fixed dose formulation of artesunate-mefloquine and standard dose artesunate and mefloquine as loose tablets in healthy normal volunteers in Thailand.
puce Current Controlled Trials
puce Results in Journal of Bioequivalence & Bioavailability (2010)

Mae Sot – ISRCTN10364429 [Completed]
A randomised, open study to assess the safety and efficacy of a new artesunate-mefloquine coformulation with an equivalent dose regimen of the individual drugs for the treatment of acute uncomplicated falciparum malaria in Thailand.
puce Current Controlled Trials
puce Results in Tropical Medicine & International Health (2006)

 BKK – ISRCTN24192353 [Completed]
A randomised open label trial to assess the efficacy, safety, and pharmacokinetic parameters of a fixed dose formulation of artesunate-mefloquine and standard dose artesunate and mefloquine as loose tablets for treatment of uncomplicated falciparum malaria in Thailand.
puce Current Controlled Trials
puce Results in Antimicrobial Agents and Chemotherapy (2010)