While exploring how DNDi can lend support, capacity, assets, and expertise in support of the COVID-19 response in resource-constrained settings, our top priority is to ensure the health, safety, and well-being of the people currently enrolled in our clinical trials, and of our staff and partners. Many of the people participating in clinical studies have serious illnesses, some life-threatening, for which they are receiving treatment. DNDi has a duty of care to continue their treatment during this time while ensuring their safety, maintaining compliance with good clinical practice and safety reporting obligations, and maintaining trial data integrity.

DNDi has established a Clinical Trials Task Force to evaluate the safety and feasibility of the conduct of our ongoing clinical trials, discuss the status of our studies and make recommendations to the senior executive regarding any necessary changes. The Clinical Trials Task Force is taking into consideration recently issued guidance from the World Health Organization, European Medicines Agency, and the U.S. Food and Drugs Administration, as well as national and local guidance.

The table below provides a summary of the status and any changes to planned and ongoing clinical trials. It will be updated as needed.

Last update: 1 April 2020

 

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Study

Disease

Country

Status

Study protocol approved but no patient yet enrolled

DNDi-MILT-08-CL

(Phase III)

Cutaneous leishmaniasis

Brazil, Bolivia, Panama, Peru

Preparatory work will continue. Patient enrolment, originally planned for Oct. 2020, will be re-evaluated as actions progress.

 

Study protocols in preparation

DNDi-OXA-04-HAT

(Phase II/III, HAT-seropositives study)

Sleeping sickness

 

Preparation of these trials will continue as far as possible. Study start dates will be re-evaluated as actions progress.

DNDi-OXA-05-HAT

(Phase IIIb, “Acozi-kids” study)

Sleeping sickness

 

DNDi-0690-02

(Phase I, multiple ascending dose)

Visceral leishmaniasis

 

DNDi-EMO-04

(Phase II)

River blindness

 

DNDi-TYL-01

(Phase II)

River blindness

 

DNDi-5FC-01-CM

Cryptococcal meningitis

 

 

Phase I* studies with healthy volunteers

DNDi-6148-01

(Phase I, multiple ascending dose)

Leishmaniaisis

 

Enrolment has been put on hold.

No new Phase 1 trials will be started at this time, according to the recommendation of the Clinical Trials Task Force and approved by the DNDi executive team.

 

Study protocol approved and patient enrolment completed – follow-up phase

DNDi-RDV-04-HCV (Bioequivalence, Phase 1)

Hepatitis C

Malaysia

Clinical phase completed. Trial activities to continue to close out as far as possible.

DNDi-PedHIV-002

(“LIVING” study, Phase IIIb)

Paediatric HIV

Kenya, Uganda, Tanzania

Clinical phase completed. Using remote monitoring as much as possible in Kenya. Allowing on-site monitoring in accordance with national guidelines and the epidemiological situation.

DNDi-FEX-09-HAT

(Phase IIIb)

Sleeping sickness

Democratic Republic of Congo, Guinea

Study treatment completed. Follow-up visits are continuing with the situation closely monitored by the teams, according to hospital policies and national guidelines.

DNDi-OXA-02-HAT

(Phase II/III)

Sleeping sickness

Democratic Republic of Congo, Guinea

Study treatment completed. Follow-up visits will continue with the situation closely monitored by the teams, according to SwissTPH (responsible for monitoring), hospital policies, and national guidelines.

DNDi-OXA-03-HAT

(Mass balance, Phase I)

Sleeping sickness

UK

For planned follow-up visits, consulting with the authorities.

DNDi-MILT COMB-01-PKDL

(Phase II)

Post-kala-azar dermal leishmaniasis

Bangladesh, India

All patients have completed treatment and the 12-month follow-up visit. Extended 24-month follow-up visits planned for mid-2020 will go ahead if possible, according to national guidelines and authorities.

 

Study protocol approved and patient enrolment ongoing as of March 2020

DNDi/SOF/RDV-01-HCV

(“STORM-C” study)

Hepatitis C

Malaysia, Thailand

Recruitment of new patients was put on hold on 17 March 2020. Now ensuring treatment continuity and safety assessments of ongoing patients through home-based care and delivery at home of study drugs.

DNDi-4in1-01-PHIV

(“LOLIPOP” study)

Paediatric HIV

Uganda

Trial currently delayed. Plans for moving ahead will first be evaluated by the Clinical Trials Task Force.

DNDi-FEX-07-HAT

(Phase II/III)

Sleeping sickness

Malawi, Uganda

Patient enrolment continues in Malawi and monitoring plans being developed. Study will not start in Uganda for now. Close monitoring of the COVID-19 situation with the relevant authorities.

DNDi-MILT/PM-01-VL

(Phase III)

Visceral leishmaniasis

Ethiopia, Kenya, Sudan, Uganda

Patient enrolment is continuing, with 29 patients remaining to be enrolled in the coming four weeks. For follow-ups, using local monitors when possible. Closely monitoring the COVID-19 situation in countries/sites with the relevant authorities

DNDi-MILT COMB-02-PKDL

(Phase II)

Post-kala-azar dermal leishmaniasis

Sudan

With local investigators, assessing human resources and feasibility to continue patient enrolment. Follow-up visits to continue with close monitoring by the teams, according to hospital and national guidelines.

DNDi-FOSR-04-MYC

(Phase II)

Mycetoma

Sudan

Patient enrolment has been paused pending the arrival of a new shipment of study drugs. Existing supply has been secured for current study participants. Patient follow-ups to continue, according to hospital and national guidelines.

DNDi recognizes the potential value to researchers in public health, and other actors, of the data gathered in the course of its research and development activities.

DNDi also recognizes the ethical imperative to share and disseminate its data responsibly in order to contribute to knowledge for the improvement of lives of neglected patients whose needs are often overlooked as research priorities, while respecting the rights of those patients.

DNDi commits to sharing its clinical trial data in a manner that respects participants in medical research and maximizes the benefits to participants and society, while minimizing any potential harm. In 2017, we signed the World Health Organization’s Joint statement on public disclosure of results from clinical trials.

You can read more about DNDi’s commitment to data sharing in the DNDi Guiding Principles on the Sharing of Clinical Trial Data.

Researchers who would like access to DNDi clinical data are requested to fill out a request form: PDF

Please send completed forms or inquiries to CTdata@dndi.org.

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 adults and children with HAT due to T.b. Rhodesiense Phase II/III

NCT03974178 | Malawi, Uganda

A multicentre, non-randomized clinical trial assessing effectiveness and safety of fexinidazole in adults and children with human African trypanosomiasis (HAT) due to T.b. Rhodesiense.

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.

 

Last update: February 2018

Visceral Leishmaniasis in Asia

Pharmacovigilance study Phase IV

CTRI/2012/08/002891  |  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).

 

Last update: February 2018

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

NCT03587766  |  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.

 

Last update: July 2018

LIVING Study Phase III

NCT02346487 |  Kenya, Uganda

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

 

LOLIPOP Study Phase I/II

NCT03836833 | Uganda

Lopinavir/r/ Lamivudine/ Abacavir as an easy-to-use paediatric formulation.

 

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.

 

Last update: February 2019

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.

 

Last update: February 2018

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.

 

Last update: February 2018

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.

 

Ravidasvir Phase I

NCT03602300 |  Malaysia  

Open-label, crossover study to evaluate the relative bioavailability of a tablet formulation of ravidasvir versus the capsule formulation of ravidasvir in healthy adult subjects.

 

Last update: September 2018

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.

 

Last update: May 2017