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Clinical Trial Protocols

Human African Trypanosomiasis

NECT-FIELD study
 - NCT00906880
Clinical Study to Assess the Tolerability, Feasibility and Effectiveness of Nifurtimox and Eflornithine 
(NECT) for the Treatment of Trypanosoma Brucei Gambiense Human African Trypanosomiasis 
(HAT) in the Meningo-Encephalitic Phase (NECT-FIELD)
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Fexinidazole - NCT00982904
Human African Trypanosomiasis: First in Man Clinical Trial of a New Medicinal Product, 
the Fexinidazole
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Fexinidazole - NCT01340157
Fexinidazole (1200mg) Bioavailability Under Different Food Intake Conditions
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Fexinidazole - NCT01483170
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
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Efficacy - Safety of Eflornithine-Nifurtimox Combination - NCT00146627
Clinical Study Comparing the Nifurtimox-Eflornithine Combination With the Standard Eflornithine Regimen for the Treatment of Trypanosoma Brucei Gambiense Human African Trypanosomiasis in the Meningoencephalitic Phase
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Oxaboroles SCYX-7158 - NCT01533961
Human African Trypanosomiasis: First in Man Clinical Trial of a New Medicinal Product, the SCYX-7158
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Fexinidazole - NCT01685827
Pivotal Study of Fexinidazole for Human African Trypanosomiasis in Stage 2 (Phase II-III)
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Leishmaniasis

VL Combination Therapy in Asia

Comparison combination regimens vs. AmBisome Alone, Bangladesh - NCT01122771
Phase III, Study of Three Short Course Combination Regimens (Ambisome®, Miltefosine, Paromomycin) Compared With AmBisome® Alone for the Treatment of Visceral Leishmaniasis in Bangladesh 
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Evaluation of different combination treatments, India - NCT00696969
Safety and Efficacy Study to Evaluate Different Combination Treatment Regimens for Visceral Leishmaniasis (India)
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Combination Therapy in Indian Visceral Leishmaniasis - NCT00523965

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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 - CTRI/2012/08/002891 
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VL Combination Therapy in Africa

Evaluation of different combination treatments, Eastern Africa - NCT01067443
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  
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Dosage of Ambisome, Ethiopia - NCT00832208 
Open-Label, Sequential Step, Safety and Efficacy Study to Determine the Optimal Single Dose of Ambisome for Patients With Visceral Leishmaniasis (Ethiopia) 
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SSG vs PM vs SSG&PM - NCT00255567
Efficacy/Safety of Sodium Stibogluconate (SSG) Versus Paromomycin (PM) and SSG/PM Combination to Treat V Leishmaniasis (Ethiopia, Kenya, Sudan, Uganda) 
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VL in Latin America

Comparison of Drugs for VL treatment in Brazil- NCT01310738

Efficacy and Safety Study of Drugs for Treatment of Visceral Leishmaniasis in Brazil (LVBrasil) 
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Cutaneous Leishmaniasis


Imiquimod for Cutaneous Leishmaniasis - NCT00257530 
Imiquimod Plus Antimony Immunochemotherapy for Cutaneous Leishmaniasis
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Chagas Disease

E1224 - NCT01489228
Proof-of-Concept Study of E1224 to Treat Adult Patients With Chagas Disease
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Optimization of sampling procedure for PCR technique to assess - NCT01678599
Parasitological response for patients with Chronic Chagas Disease treated with benznidazole
in Aiquile, Bolivia. 
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Benznidazole in Children- NCT01489228
 
Population Pharmacokinetics Study of Benznidazole in Children with Chagas Disease
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Malaria


ASAQ


ASAQ HNV - ISRCTN70132716
Artesunate and Amodiaquine: tolerability and pharmacokinetic study in healthy normal volunteers of non-fixed and fixed combination (Malaysia) More

Burkina Faso - ISRCTN07576538
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 More

Inde - ISRCTN84408319
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 More

Kenya - ISRCTN16409445
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 More

Liberia: Efficacy - ISRCTN51688713
Efficacy of amodiaquine-artesunate and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Nimba county, Liberia More

Tolerability - ISRCTN40020296
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 More


ASMQ


India : ISRCTN70618692
Assessment of efficacy, safety and population-pharmacokinetics of the fixed-dose combination of artesunate-mefloquine in the treatment of acute uncomplicated Plasmodium falciparummalaria in India More

HNV - ISRCTN22508774
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 (Thailand) More

BKK - ISRCTN24192353
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 (Thailand) More

Mae Sot - ISRCTN10364429
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 (Thailand) More



Paediatric HIV

South Africa - PACTR201302000426554
Pharmacokinetics of lopinavir/ritonavir superboosting in infants and young children co-infected with HIV and TB
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