Safety and Efficacy of Annual or Biannual Doses of Moxidectin or Ivermectin for Onchocerciasis
- Conditions
- Onchocerciasis
- Registration Number
- PACTR202004639229710
- Lead Sponsor
- Medicines Development for Global Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1000
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method