This is a Phase 3 study comparing the efficacy, safety and tolerability of moxidectin and ivermectin in subjects infected with Onchocerca volvulus, which is the parasite that causes river blindness. Subjects participating in the study will be randomly assigned (by a 2 to1 ratio) to receive one orally-administered dose of either moxidectin or ivermectin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,497
Single dose of moxidectin 2 mg oral tablet x 4
Single dose of ivermectin 3 mg oral tablet x 2, 3 or 4
Centre de Recherche Clinique de Butembo - Université Catholique du Graben
Butembo, Democratic Republic of the Congo
Centre de Recherche en Maladies Tropicales de l'Ituri
Rethy, Democratic Republic of the Congo
Onchocerciasis Chemotherapy Research Center
Hohoe, Ghana
Liberian Institute for Biomedical Research Clinical Research Center
Bolahun, Lofa County, Liberia
skin microfilaria density (mf/mg)
Time frame: 12 months
skin microfilaria density (mf/mg)
Time frame: 1 month
skin microfilaria density (mf/mg)
Time frame: 6 months
skin microfilaria density (mf/mg)
Time frame: 18 months
skin microfilaria reduction from baseline
Time frame: 1 month
skin microfilaria reduction from baseline
Time frame: 6 months
skin microfilaria reduction from baseline
Time frame: 12 months
skin microfilaria reduction from baseline
Time frame: 18 months
proportion of subjects with undetectable levels of skin microfilaria
Time frame: 1 month
proportion of subjects with undetectable levels of skin microfilaria
Time frame: 6 months
proportion of subjects with undetectable levels of skin microfilaria
Time frame: 12 months
proportion of subjects with undetectable levels of skin microfilaria
Time frame: 18 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
percent reduction in microfilaria levels in the anterior chamber of the eye
Time frame: 12 months