About this trial
This clinical trial compares two treatments - ivermectin and moxidectin - to learn which is better at reducing the proportion of people with onchocerciasis (river blindness) when given through mass drug administration (MDA) in Angola. Both drugs are approved by the United States Food and Drug Administration (FDA) to treat this disease. The study also explores how these treatments affect other infections common in the region, including intestinal worms (soil-transmitted helminths) and scabies.
The trial aims to answer the following key questions:
* How do moxidectin and ivermectin compare in reducing the prevalence (how common the disease is) and intensity (amount of parasites per person) of onchocerciasis in the community? * Do the treatments differ in their effect on the prevalence and intensity of soil-transmitted helminths and the prevalence of scabies? * Does moxidectin reduce transmission of onchocerciasis more effectively than ivermectin, based on genetic testing of parasites in people and lab testing of the blackflies that carry the infection? * How many more years of treatment would be needed to reach elimination with each drug, based on mathematical disease modelling? * How do communities feel about receiving moxidectin versus ivermectin, and what factors help or make it harder to carry out MDA programs with moxidectin versus ivermectin?
The study takes place in Bié Province, Angola, and involves 20 groups of villages randomly assigned to receive either moxidectin or ivermectin once a year for four years. Prior to every round of MDA, researchers will collect skin, stool and blood samples from a sample of the people living in the study area. We believe the results will help guide global policy on the use of moxidectin in efforts to eliminate onchocerciasis and control related diseases.
Eligibility criteria
Qualifiers
Male or female children and adults
Residents in the villages selected for MDA treatment
Disqualifiers
Arm 1 (ivermectin): children under the age of 5 and/or under 90 cm of height
Arm 2 (moxidectin): children under the age of 12 years (who will receive ivermectin if they are at least 90 cm in height/5 years of age and above).
Arm 1 (ivermectin): Women breast-feeding babies under 45 days of age
Arm 2 (moxidectin): All breastfeeding women (who will be offered ivermectin if their infants is at least 45 days old)
Trial design
Treatments tested in this trial
- Moxidectin
- Ivermectin
Treatment groups
Sponsors and collaborators
Kirby Institute
Lead sponsor
Emory University
Collaborator
La Trobe University
Collaborator
Murdoch Childrens Research Institute
Collaborator
Medicines Development for Global Health
Collaborator
University of Melbourne
Collaborator
Swiss Tropical & Public Health Institute
Collaborator
University of Ottawa
Collaborator
The Mentor Initiative
Collaborator
Erasmus Medical Center
Collaborator
Ministry of Health, Angola
Collaborator
The END Fund
Collaborator
Center for Research on Filariasis and Other Tropical Diseases, Cameroon
Collaborator
World Health Organization
Collaborator