Onchocerciasis
Conditions
Interventions
Sponsors
Medicines Development for Global Health
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent, or assent with parental or guardian written consent. 2. Mean = 10 O. volvulus mf/mg skin, determined by four skin snips. 3. Living in a village selected for the study. 4. Age = 12 years. 5. All female participants of childbearing potential must commit to the use of a reliable method of birth control for the duration of treatment and until 3 months after completion of dosing with investigational product.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breast-feeding. 2. 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. 3. Has received ivermectin, oral diethylcarbamazine (DEC) or doxycycline (for > 2 weeks) within 6 months of Baseline. 4. Has received treatment with an investigational agent within the last 30 days (or 5 half-lives, whichever is longer) prior to Baseline. 5. Known or suspected allergy to ivermectin or moxidectin or their excipients. 6. Self-reported planned or ongoing activities within the study period that would make it unlikely that a participant will be available for all planned treatment rounds and follow-up examinations. 7. Weight > 88 kilograms. 8. Infection with Loa loa.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of full analysis set participants in the moxidectin annual and biannual treatment arms with zero O. volvulus skin microfilariae at both Months 6 and 12; microfilaridermia is determined by the count of four skin snips for each participant at each assessment;Safety across all dose groups will be evaluated by the incidence and severity of adverse events (AEs) and measurement of vital signs up to and including Month 36 and liver function tests up to and including Month 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Sustained microfilariae response, defined as zero O. volvulus skin microfilariae sustained at all post-Baseline assessments;Sustained ocular microfilariae response, defined as zero live O. volvulus microfilariae in the anterior chambers of the eyes at all post-Baseline assessments in those with live microfilariae in the anterior chambers of the eyes before the first treatment;Mean and median percent reduction (from pre-treatment) of skin microfilariae density and live microfilariae in the anterior chambers of the eyes;The proportion of participants in each treatment group with zero skin microfilariae and zero live microfilariae in the anterior chambers of the eyes at each post-Screening assessment;Mean skin microfilariae density at each post-Screening assessment and the mean and mean change from baseline, for the number of live microfilariae in the anterior chambers of the eyes at each post-Screening assessment in those with live microfilariae in the anterior chambers of the eyes before the first treatment | — |
Countries
Democratic Republic of the Congo
Contacts
Public ContactSally Kinrade
Moxidectin for Onchocerciasis Project Leader
Outcome results
None listed