Study Comparing Moxidectin And Ivermectin In Subjects With Onchocerca Volvulus Infection

Phase 3

Completed

• Conditions: Onchocerciasis
• Interventions: Drug: Moxidectin; Drug: Ivermectin

• Registration Number: NCT00790998
• Lead Sponsor: Medicines Development for Global Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-13
• Study First Submitted QC: 2008-11-13
• Study First Posted: 2008-11-14
• Study Start: 2009-04
• Primary Completion: 2012-02
• Study Completion: 2012-05
• Status Verified: 2013-11
• Last Update Submitted: 2018-01-29
• Last Update Posted: 2018-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1497

Inclusion Criteria

• Male and female subjects with Onchocerca volvulus infection

Exclusion Criteria

• Pregnant or breast feeding women; coincidental loiasis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moxidectin	Moxidectin	Moxidectin 8mg
Ivermectin	Ivermectin	Ivermectin 150 mcg/kg

Primary Outcome Measures

Name	Time	Method
skin microfilaria density (mf/mg)	12 months

Secondary Outcome Measures

Name	Time	Method
skin microfilaria density (mf/mg)	18 months
skin microfilaria reduction from baseline	18 months
proportion of subjects with undetectable levels of skin microfilaria	18 months
percent reduction in microfilaria levels in the anterior chamber of the eye	12 months

Trial Locations

Locations (4)

Centre de Recherche en Maladies Tropicales de l'Ituri; 🇨🇩 Rethy, Congo, The Democratic Republic of the

Liberian Institute for Biomedical Research Clinical Research Center; 🇱🇷 Bolahun, Lofa County, Liberia

Centre de Recherche Clinique de Butembo - Université Catholique du Graben; 🇨🇩 Butembo, Congo, The Democratic Republic of the

Onchocerciasis Chemotherapy Research Center; 🇬🇭 Hohoe, Ghana