Oxaboroles

Oxaborole 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

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)