ACT Africa Baseline Study Group
A pooled analysis of baseline information on parasitological response to artemisinin combination therapy in Africa.
Aims:
• To define the spectrum of early parasitological response following ACT treatment in African clinical trials, and the cofactors affecting early and late treatment outcome
• To investigate geographical and temporal trends in early parasitological outcome which, after controlling for confounding factors, may indicate declining artemisinin sensitivity
Status: Open call for participants.
ACT Dosing Study Group
Assessing the effect of mg/kg dosing strategies on the risk of treatment failure in patients treated with currently recommended ACTs.
Aims:
• To determine the mg/kg dosing range of the clinically-adopted ACT partner drugs lumefantrine, piperaquine and amodiaquine
• To investigate the effects of mg/kg dosing on clinical outcome
Status: Open call for participants.
Amodiaquine PK/PD Study Group
A pooled individual patient PK/PD data analysis to provide the necessary evidence to inform recommendations on dosage and use in key target populations.
Aims:
• To refine the definition of amodiaquine (desethylamodiaquine) therapeutic concentrations
• To determine patient factors that cause changes in amodiaquine pharmacokinetics substantial enough to compromise efficacy
Status: Final call for participants; data collection ongoing.
Artemisinin Parasite Clearance Study Group
A pooled analysis of parasite clearance data after treatment with an artemisinin derivative either alone or in combination with other antimalarials (ACTs).
Aims:
• To provide reference parasite clearance estimates stratified by location, treatment, study population and date
• To examine host and parasite factors affecting parasite clearance
Status: Data collection closes to new participants May 2012; curation and analysis due June 2012.
ASAQ/AL Molecular Marker Study Group
Investigating the role of candidate molecular markers of lumefantrine and amodiaquine resistance in clinical outcomes of ACTs.
Aim:
• To establish whether known pfcrt and pfmdr1 gene polymorphisms play a role in conferring clinically relevant resistance
Status: Final call for participants; data collection ongoing.
Lumefantrine PK/PD Study Group
Investigating how often treatment failures are explained by inadequate drug exposure rather than drug resistance.
Aims:
• To refine the definition of the pharmacokinetic determinants of treatment response
• To determine patient factors that cause changes in lumefantrine pharmacokinetics substantial enough to compromise the efficacy (or safety) of artemether-lumefantrine
Status: Data collection completed February 2012; pooled analysis ongoing; preliminary results by Spring 2012.
Sulfadoxine-Pyrimethamine PK/PD Study Group
An analysis of pooled individual patient PK/PD data to provide the necessary evidence to inform recommendations on dosage and use in key target populations.
Aims:
• To refine the definition of sulfadoxine-pyrimethamine therapeutic concentrations
• To determine patient factors that cause changes in sulfadoxine-pyrimethamine pharmacokinetics substantial enough to compromise efficacy
Status: Open call for participants.
