Oxaboroles

Acoziborole (SCYX-7158) pivotal study in adults with stage 1 and stage 2 HAT  Phase II/III

NCT03087955 |  Democratic Republic of the Congo

A pivotal study assessing efficacy and safety of acoziborole (SCYX-7158) in patients with stage 1 and stage 2 human African trypanosomiasis due to T.b. Gambiense.

Acoziborole (SCYX-7158) Phase I

NCT01533961 |  France  |  Completed

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

 

Fexinidazole

Fexinidazole study, in adults and children, in-and out-patients  Phase III

NCT03025789  |  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 study in children with both stage 1 + stage 2 HAT  Phase II/III

NCT02184689  |  Democratic Republic of the Congo | Completed

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 in adults with stage 1 + early stage 2 HAT  Phase II/III

NCT02169557  |  Democratic Republic of the Congo | Completed

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 pivotal study Phase II/III

NCT01685827  |  Central African Republic, Democratic Republic of the Congo | Completed

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

Fexinidazole – Bioequivalence study Phase I

NCT02571062  | France  |  Completed

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

Fexinidazole Phase I

NCT01340157  |  France  |  Completed

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

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

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.

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/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.

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.

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.

 

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).

 

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.

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.

 

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.

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.

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.

 

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.

Imiquimod plus antimony immunochemotherapy Phase III

NCT00257530 |  Peru |  Completed

Imiquimod plus antimony immunochemotherapy for cutaneous leishmaniasis.

Topical amphotericin B cream Phase I/II

NCT01845727 |  Colombia  |  Completed

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

Benznidazole new doses improved treatment & therapeutic associations (BENDITA) Phase II

NCT03378661  |  Bolivia 

Safety and efficacy trial to evaluate different oral benznidazole monotherapy and benznidazole/E1224 combination regimens for the treatment of adult patients with chronic indeterminate Chagas disease

 

Fexinidazole proof-of-concept Phase II

Spain

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

 

Fexinidazole adult dosing regimens Phase II

NCT02498782 |  Bolivia |  Completed

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

 

Parasitological response assessment Phase IV

NCT01678599  |  Bolivia  |  Completed

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

 

Paediatric benznidazole Phase IV

NCT01549236 |  Argentina |  Completed

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

 

E1224 Phase II

NCT01489228 |  Bolivia  |  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  |  Completed

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

 

Emodepside multiple ascending dose Phase I

NCT03383614  |  United Kingdom

A phase 1 multiple-dose-escalation study to investigate safety, tolerability, and pharmacokinetics of emodepside after oral dosing in healthy male subjects.

 

Emodepside relative bioavailability study of immediate release tables and solutions Phase I

NCT03383523  |  United Kingdom

This study evaluates 2 new immediate release-tablet formulations of emodepside and they will be compared to the oral liquid service formulation used in the emodepside single-ascending dose study.

 

Emodepside single ascending dose Phase I

NCT02661178  |  United Kingdom | Completed

Emodepside single-ascending dose for onchocerciasis.

Fosravuconazole Phase II

NCT03086226  |  Sudan  

This study is a single-center, comparative, randomized, double-blind, parallel-group, active-controlled, clinical superiority trial of Fosravuconazole versus Itraconazole combined with surgery in subjects with eumycetoma in Sudan.

 

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 ASAQ

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.