The purpose of this phase 3b study is to determine the safety of a single dose of moxidectin, compared to a single dose of ivermectin, in individuals living in onchocerciasis endemic areas and in individuals living in onchocerciasis endemic areas with high levels of lymphatic filariasis co-endemicity receiving concomitant albendazole.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
12,979
2 mg tablets, encapsulated for blinding
3 mg tablets, encapsulated for blinding
400 mg tablets
Centre Suisse de Recherches Scientifiques en Coˆte d'Ivoire
Abidjan, Côte d’Ivoire
Centre de Recherche pour les Maladies Tropicales Negligees
Rethy, Ituri, Democratic Republic of the Congo
Incidence and Severity of Treatment Emergent Adverse Events
Participant incidence rates of treatment emergent adverse events following a single dose of moxidectin versus a single dose of ivermectin will be assessed separately by endemic area. Treatment emergent adverse events may also be pooled across both endemic areas (pooled monotherapy and combination therapies separately for moxidectin and ivermectin), provided a qualitative assessment shows they are similar enough to enable the interpretation of the pooled analysis.
Time frame: Up to 3 months
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