Oxaboroles

Acoziborole (SCYX-7158) Phase I

NCT01533961 |  France  |  Completed

Human African trypanosomiasis: first-in-man clinical trial of a new medicinal product, SCYX-7158.

 

Fexinidazole

Fexinidazole Phase III

NCT03025789  |  The Democratic Republic of the Congo 

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

Fexinidazole – Bioequivalence study Phase I

NCT02571062  | France  |  Completed

Bioequivalence Study – Reference clinical fexinidazole tablet versus proposed market formulation.

Fexinidazole Phase II/III

NCT02184689  |  The Democratic Republic of the Congo

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.

Fexinidazole  Phase II/III

NCT02169557  |  The Democratic Republic of the Congo

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.

Fexinidazole Phase I

NCT01340157  |  France  |  Completed

Fexinidazole (1200mg) bioavailability under different food intake conditions.

Fexinidazole Phase II/III

NCT01685827  |  Central African Republic

Pivotal Study of fexinidazole for human African trypanosomiasis in stage 2 (Phase II-III).

Fexinidazole  Phase I

NCT01483170  |  France  |  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.

Fexinidazole  Phase I

NCT00982904  |  France  |  Completed

Human African trypanosomiasis: first-in-man clinical trial of a new medicinal product, fexinidazole.

 

 

NECT

NECT-FIELD study Phase IV

NCT00906880  |  Congo  |  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).

Eflornithine-nifurtimox combination   Phase III 

NCT00146627  |  The Democratic Republic of the Congo  |  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.

 

Visceral Leishmaniasis in Asia

Pharmacovigilence study – 1 Phase IV

CTRI/2012/08/00289  |  India

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.

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 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.

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.

 

Visceral Leishmaniasis in Latin America

Comparison of VL drugs Phase IV

NCT01310738 |  Brazil  |  Terminated

Efficacy and safety study of drugs for treatment of visceral leishmaniasis in Brazil (LVBrasil).

 

HIV/VL

Ambisome® / miltefosine Phase III

NCT02011958 |  Ethiopia

Efficacy trial of Ambisome® given alone and Ambisome® given in combination with miltefosine for the treatment of VL HIV positive Ethiopian patients.

 

PKDL

Follow-up study of PKDL in VL patients

CTRI/2016/06/007020  |  India

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  |  Completed

Thermotherapy + a short course of miltefosine for the treatment of uncomplicated cutaneous leishmaniasis in the New World.

Topical amphotericin B cream Phase I/II

NCT01845727 |  Colombia

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

Imiquimod plus antimony immunochemotherapy Phase III

NCT00257530 |  Peru |  Completed

Imiquimod plus antimony immunochemotherapy for cutaneous leishmaniasis.

Fexinidazole adult dosing regimens Phase II

NCT02498782 |  Bolivia 

Study to evaluate fexinidazole dosing regimens for the treatment of adult patients with Chagas disease.

 

Parasitological response assessment Phase IV

NCT01678599  |  Bolivia 

Optimization of PCR technique to assess parasitological response for patients with chronic Chagas disease (PCR).

 

Paediatric benznidazole Phase IV

NCT01549236 |  Argentina

Population pharmacokinetics study of benznidazole in children with Chagas disease (pop PK Chagas).

 

E1224 Phase II

NCT01489228 |  Argentina  |  Status: Completed

Proof-of-concept study of E1224 to treat adult patients with Chagas disease.

LIVING Study Phase III

NCT02346487 |  Kenya, Uganda

Lopinavir/ritonavir pellets with dual NRTIs  implemenation study  in infants and young children.

 

Ritonavir superboosting study for TB/HIV Phase IV

NCT02348177  |  South Africa

Pharmacokinetics of lopinavir/ritonavir superboosting in Infants and young children co-infected with HIV and TB.

 

Emodepside Phase I

BAY 44-4400  |  United Kingdom

Emodepside single-ascending dose for onchocerciasis.

Sofosbuvir/Ravidasvir Combination Therapy Phase II/III

NCT02961426  |  Malaysia, Thailand 

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.

 

ASAQ

Tolerability Phase IV

ISRCTN40020296 |  Liberia  |  Status: Completed

A phase IV randomized 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.

Efficacy

ISRCTN51688713 |  Liberia  |  Status: Completed

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

Combination & monotherapy

ISRCTN84408319  |  India  |  Status: Completed

Multicentre, open-label randomized 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.

Oral ASMQ

ISRCTN07576538 |  Burkina Faso  |  Status: Completed

A randomized, controlled, open-label, parallel-group study comparing the efficacy and safety of an oral artesunate-amodiaquine fixed-dose combination therapy over three subsequent days to an equivalent dose regimen of the individual drugs for the treatment of children with Plasmodium falciparum.

Pharmokinetics, efficacy, tolerability

ISRCTN16409445 |  Kenya  |  Status: Completed

Open-label randomized 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.

ATAQ EASY  Phase III

NCT00316329 |  Cameroon, Madagascar, Senegal, Mali  |  Status: 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).

ASAQ HNV  

ISRCTN70132716 | Malaysia  |  Status: Completed

Artesunate and Amodiaquine: tolerability and pharmacokinetic study in healthy normal volunteers of non-fixed and fixed combination in Malaysia.

 

 

ASMQ

Pharmacokinetics of ASMQ FDC  Phase IV

ISRCTN17472707 & PACTR201202000278282   |  Tanzania, Burkina Faso, Kenya  |  Status: Completed

A multicentre, open-label, prospective, randomized, 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.

Assessment of efficacy  Phase III

ISRCTN70618692  |  India  |  Status: 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.

HNV

ISRCTN22508774  |  Thailand  |  Status: 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.

Mae Sot  

ISRCTN10364429  |  Thailand  |  Status: Completed

A randomized, 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.

BKK 

ISRCTN24192353   |  Thailand  |  Status: Completed

A randomized 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.