Moxidectin Versus Ivermectin as Mass Drug Administration for the Control of Onchocerciasis and Other Neglected Tropical Diseases

NCT07145736 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 52000

Last updated 2025-11-21

No results posted yet for this study

Summary

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.

Conditions

  • Onchocerciasis
  • Ascaris Lumbricoides Infection
  • Trichuris Trichiura; Infection
  • Hookworm Infections
  • Scabies

Interventions

DRUG

Moxidectin

2 mg tablets

DRUG

Ivermectin

3 mg tablets

Sponsors & Collaborators

  • Emory University

    collaborator OTHER
  • La Trobe University

    collaborator OTHER
  • Murdoch Childrens Research Institute

    collaborator OTHER
  • Medicines Development for Global Health

    collaborator OTHER
  • University of Melbourne

    collaborator OTHER
  • Swiss Tropical & Public Health Institute

    collaborator OTHER
  • University of Ottawa

    collaborator OTHER
  • The Mentor Initiative

    collaborator OTHER
  • Erasmus Medical Center

    collaborator OTHER
  • Ministry of Health, Angola

    collaborator UNKNOWN
  • The END Fund

    collaborator UNKNOWN
  • Center for Research on Filariasis and Other Tropical Diseases, Cameroon

    collaborator OTHER
  • World Health Organization

    collaborator OTHER
  • Kirby Institute

    lead OTHER_GOV

Principal Investigators

  • Susana V Nery, PhD · Kirby Institute, University of New South Wales, Australia

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-04
Primary Completion
2029-03-31
Completion
2029-06-30
FDA Drug
Yes

Countries

  • Angola

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07145736 on ClinicalTrials.gov