A Phase 4 interventional study of Moxidectin and Ivermectin in Onchocerciasis, Ascaris Lumbricoides Infection and Trichuris Trichiura; Infection, sponsored by Kirby Institute. Recruiting at 1 site in Angola. Open to participants aged 5 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-21.
Sponsored by Kirby Institute · Phase 4, Interventional, and Other
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:
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.
35 studies on the registry are indexed under Onchocerciasis; 7 are open to participants now.
This study's planned enrollment of 52,000 is above the median of 216 across 26 interventional studies indexed under Onchocerciasis.
Browse Onchocerciasis studies →Kirby Institute is the lead sponsor of 94 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Single oral dose of moxidectin treatment 8 mg (4 tablets of 2 mg of moxidectin), once per year
Drug: Moxidectin
Single oral dose of ivermectin treatment with approximately 150 µg/kg determined based on height (between 1 and 4 tablets of 3 mg of ivermectin), once per year
Drug: Ivermectin
2 mg tablets
3 mg tablets
Prevalence of Onchocerca volvulus microfilariae
Prevalence of O. volvulus microfilariae at 36 months in skin snips, the marker most likely to show change in the shorter term as demonstrated by the therapeutic trials
Time frame: 36 months after the first intervention
Prevalence of O. volvulus microfilaria/mg skin
Time frame: 12, 24 and 36 months after the first intervention
Microfilariae density (mean, median)
Time frame: 12, 24 and 36 months after the first intervention
Prevalence of nodules
Time frame: 12, 24 and 36 months after the first intervention
Prevalence of onchocerciasis skin disease
Time frame: 12, 24 and 36 months after the first intervention
Proportion of black flies with infective O. volvulus larvae
Infection assessed based on all 3 are markers recommended by WHO to define population-level elimination
Time frame: 12, 24 and 36 months after the first intervention
Prevalence of anti-Ov-16
Time frame: 12, 24 and 36 months after the first intervention
Prevalence of Ascaris lumbricoides
Measured through qPCR
Time frame: 12, 24 and 36 months after the first intervention
Intensity of Ascaris lumbricoides infection
Measured through qPCR
Time frame: 12, 24 and 36 months after the first intervention
Prevalence of Trichuris trichiura
Measured through qPCR
Time frame: 12, 24 and 36 months after the first intervention
Intensity of Trichuris trichiura infection
Measured through qPCR
Time frame: Baseline and 12, 24 and 36 months after the first intervention
Prevalence of hookworm
Measured through qPCR
Time frame: 12, 24 and 36 months after the first intervention
Intensity of hookworm infection
Measured through qPCR
Time frame: 12, 24 and 36 months after the first intervention
Prevalence of Strongyloides stercoralis
Measured through qPCR
Time frame: 12, 24 and 36 months after the first intervention
Intensity of Strongyloides stercoralis infection
Measured through qPCR
Time frame: 12, 24 and 36 months after the first intervention
Prevalence of scabies/impetigo
Time frame: 12, 24 and 36 months after the first intervention
Plan to share: Undecided
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Studies of the drug tested here: Moxidectin
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