Experience |
Ongoing Projects / Studies / Contracts
Aeras EDCTP C-029-402: TB vaccine
Phase II dose-finding, safety and efficacy vaccine trial, Aeras402 / Crucell Ad35, 2'700 - 4'100 infants
Countries: Kenya
Sponsor: Aeras Global TB Vaccine Foundation, EDCTP
SA ARAMF L 04454: observational study, Artesunate - amodiaquine – fixed combination ASAQ
Phase IV safety and tolerance 15’000 patients
Countries: Ivory Coast
Sponsor: Sanofi Aventis
NECT-FIELD: Nifurtimox–Eflornithine Combination Therapy for HAT
Phase IIIb effectiveness study (study design & management of 6 sites) 620 patients
Countries: Democratic Republic of Congo
Sponsor: Drugs for Neglected Diseases initiative (DNDi)
HAT LED FM: Evaluation of LED-based Fluorescence Microscopy for Diagnosis of Human African Trypanosomiasis (sleeping sickness), 290 patients
Role of PMU: Scientific advice, monitoring - 3 sites
Country: Democratic Republic of Congo
Sponsor: FIND
Past Projects / Studies / Contracts
GVXN SD-133: Phase I clinical study, investigating a novel vaccine candidate (GVXN SD133) against Shigella dysenteriae
Phase I safety and tolerance (Monitoring of 1 center in Switzerland) 40 patients
Countries: Switzerland
Sponsor: GlycoVaxyn
PMAL03: Virosome based malaria vaccine development
Phase Ib (trial management & monitoring of 1 site) 50 patients
Countries: Tanzania
Sponsor: Pevion Biotech Ltd.
DB289: Drug against first stage sleeping sickness
Phase III (study design & management of 6 sites) 270 patients
Countries: Angola, Democratic Republic of Congo, South Sudan
Sponsor: Immtech Pharmaceuticals Inc.
DB289: Drug against first stage sleeping sickness
Phase II (study design & management of 3 sites) 3 trials, total 140 patients
Countries: Angola, Democratic Republic of Congo (2)
Sponsor: Immtech Pharmaceuticals Inc.
i.v. Artesunate in children with severe malaria
Phase II safety, efficacy & PK trial (trial management & monitoring of 3 sites) 200 patients
Countries: Gabon, Malawi
Sponsor: Medicines for Malaria Venture (MMV)
Pyronaridine artesunate versus mefloquine plus artesunate in uncomplicated malaria Phase III
Safety, efficacy trial (site coordination & monitoring of 1 site;) 38 patients
Countries: Tanzania
Sponsor: Medicines for Malaria Venture (MMV)
Pyronaridine artesunate versus Coartem® in infants & children
Phase III safety, efficacy trial on (coordination & monitoring of 1 site) 90 patients
Countries: Gabon
Sponsor: Medicines for Malaria Venture (MMV)
NECT: Nifurtimox–Eflornithine Combination Therapy for human African trypanosomiasis.
Phase III trial (study design & management of 4 sites) 280 patients
Countries: Democratic Republic of Congo, Republic of Congo (site managed by MSF)
Sponsor: Drugs for Neglected Diseases initiative (DNDi)
RBx 11160: Synthetic anti-malarial drug
Phase II, dose ranging safety and efficacy study (co-ordination of 4 sites) – 255 patients
Countries: India, Thailand, Tanzania
Sponsor: Medicines for Malaria Venture (MMV)
PEV01: Virosome based malaria vaccine
Phase Ia (trial management & monitoring of 1 site) 45 patients
Countries: Switzerland
Sponsor: Pevion Biotech Ltd.
Riamet: Coartem
Phase IV safety study 140 patients
Countries: Germany, Switzerland
Sponsor: Novartis International AG