Clinical trial NCT00790998: Study Comparing Moxidectin And Ivermectin In Subjects With Onchocerca Volvulus Infection
Official title: A Single-Dose, Ivermectin-Controlled, Double-Blind, Efficacy, Safety And Tolerability Study Of Orally Administered Moxidectin In Subjects Infected With Onchocerca Volvulus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Onchocerciasis
Keywords: onchocerciasis
river blindness
onchocerca volvulus
moxidectin
ivermectin
Lead sponsor: Medicines Development for Global Health
Sponsor class: OTHER
Collaborators: name: World Health Organization
First posted: 2008-11-14
Enrollment: 1497
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects with Onchocerca volvulus infection

Exclusion Criteria:

* Pregnant or breast feeding women; coincidental loiasis

Primary outcomes:
measure: skin microfilaria density (mf/mg)
timeFrame: 12 months
Secondary outcomes:
measure: skin microfilaria density (mf/mg)
timeFrame: 1 month
measure: skin microfilaria density (mf/mg)
timeFrame: 6 months
measure: skin microfilaria density (mf/mg)
timeFrame: 18 months
measure: skin microfilaria reduction from baseline
timeFrame: 1 month
measure: skin microfilaria reduction from baseline
timeFrame: 6 months
measure: skin microfilaria reduction from baseline
timeFrame: 12 months
measure: skin microfilaria reduction from baseline
timeFrame: 18 months
measure: proportion of subjects with undetectable levels of skin microfilaria
timeFrame: 1 month
measure: proportion of subjects with undetectable levels of skin microfilaria
timeFrame: 6 months
measure: proportion of subjects with undetectable levels of skin microfilaria
timeFrame: 12 months
measure: proportion of subjects with undetectable levels of skin microfilaria
timeFrame: 18 months
measure: percent reduction in microfilaria levels in the anterior chamber of the eye
timeFrame: 12 months
Other outcomes:
Locations:
city: Butembo
country: Congo, The Democratic Republic of the
facility: Centre de Recherche Clinique de Butembo - Université Catholique du Graben
city: Rethy
country: Congo, The Democratic Republic of the
facility: Centre de Recherche en Maladies Tropicales de l'Ituri
city: Hohoe
country: Ghana
facility: Onchocerciasis Chemotherapy Research Center
city: Bolahun
country: Liberia
facility: Liberian Institute for Biomedical Research Clinical Research Center
state: Lofa County
Study officials:
affiliation: World Health Organization
name: Special Programme for Research and Training in Tropical Diseases (TDR)
role: STUDY_DIRECTOR
References:
citation: Opoku NO, Bakajika DK, Kanza EM, Howard H, Mambandu GL, Nyathirombo A, Nigo MM, Kasonia K, Masembe SL, Mumbere M, Kataliko K, Larbelee JP, Kpawor M, Bolay KM, Bolay F, Asare S, Attah SK, Olipoh G, Vaillant M, Halleux CM, Kuesel AC. Single dose moxidectin versus ivermectin for Onchocerca volvulus infection in Ghana, Liberia, and the Democratic Republic of the Congo: a randomised, controlled, double-blind phase 3 trial. Lancet. 2018 Oct 6;392(10154):1207-1216. doi: 10.1016/S0140-6736(17)32844-1. Epub 2018 Jan 18.
citation: Bakajika D, Kanza EM, Opoku NO, Howard HM, Mambandu GL, Nyathirombo A, Nigo MM, Kennedy KK, Masembe SL, Mumbere M, Kataliko K, Bolay KM, Attah SK, Olipoh G, Asare S, Vaillant M, Halleux CM, Kuesel AC. Effect of a single dose of 8 mg moxidectin or 150 mug/kg ivermectin on O. volvulus skin microfilariae in a randomized trial: Differences between areas in the Democratic Republic of the Congo, Liberia and Ghana and impact of intensity of infection. PLoS Negl Trop Dis. 2022 Apr 27;16(4):e0010079. doi: 10.1371/journal.pntd.0010079. eCollection 2022 Apr.