Safety of a Single Dose of Moxidectin Compared With Ivermectin in Individuals Living in Onchocerciasis Endemic Areas and in Individuals Living in Onchocerciasis Endemic Areas With High Levels of Lymphatic Filariasis Co-endemicity Receiving Concomitant Albendazole
Onchocerciasis
About this trial
This is an interventional treatment trial for Onchocerciasis
Eligibility Criteria
Inclusion Criteria:
- Provision of written informed consent, or assent with parental or guardian written consent
- Known O. volvulus skin microfilariae density ≥0 microfilariae/mg skin
- Living in an onchocerciasis endemic area.
- Age ≥ 12 years.
- All female participants of childbearing potential must commit to the use of a reliable method of birth control until 3 months after administration of investigational product (Month 3)
Exclusion Criteria:
- Pregnant or breast-feeding.
- Any concurrent condition that, in the opinion of the Investigator, would preclude evaluation of response to treatment or would pose undue risk to the participant's health.
- Has received ivermectin or oral diethylcarbamazine (DEC) within 30 days of Baseline.
- Has received treatment with an investigational agent within the 30 days (or 5 half-lives, whichever is longer) prior to planned investigational product administration.
- Known or suspected allergy to ivermectin or moxidectin or their excipients.
- Self-reported planned or ongoing activities within the study period that would make it unlikely that the participant will be available for follow-up examinations.
- Infection with Loa loa
Sites / Locations
- Centre de Recherche pour les Maladies Tropicales NegligeesRecruiting
- Centre Suisse de Recherches Scientifiques en Coˆte d'IvoireRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Active Comparator
Experimental
Active Comparator
Moxidectin
Ivermectin
Moxidectin with concomitant Albendazole
Ivermectin with concomitant Albendazole
In onchocerciasis endemic areas: Moxidectin 8 mg per oral on Day 0
In onchocerciasis endemic areas: Ivermectin treatment with approximately 150 µg/kg per oral determined based on height on Day 0
In onchocerciasis endemic areas with high levels of lymphatic filariasis co-endemicity: Moxidectin 8 mg per oral with concomitant albendazole 400 mg per oral on Day 0
In onchocerciasis endemic areas with high levels of lymphatic filariasis co-endemicity: Ivermectin treatment with approximately 150 microgram/kilogram (μg/kg) per oral determined based on height with concomitant albendazole 400 mg per oral on Day 0