Safety and Efficacy of Annual or Biannual Doses of Moxidectin or Ivermectin for Onchocerciasis
- Registration Number
- NCT03876262
- Lead Sponsor
- Medicines Development for Global Health
- Brief Summary
The primary purpose of this phase 3b study is to determine the safety and efficacy of moxidectin administration twice a year, compared to once a year, in maintaining undetectable levels in skin of O. volvulus microfilaria in skin, the parasite that causes river blindness.
Secondary purposes are to determine the effectiveness of moxidectin compared to ivermectin once or twice a year in maintaining undetectable levels, or reducing levels, of skin microfilaria.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 323
- Provision of written informed consent, or assent with parental or guardian written consent.
- Mean ≥ 10 O. volvulus microfilariae/mg skin, determined by four skin snips
- Living in a village selected for the study.
- Age ≥ 12 years.
- 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.
- 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, oral diethylcarbamazine (DEC) or doxycycline (for > 2 weeks) within 6 months of Baseline.
- Has received treatment with an investigational agent within the last 30 days (or 5 half-lives, whichever is longer) prior to Baseline.
- 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 a participant will be available for all planned treatment rounds and follow-up examinations.
- Weight > 88 kg.
- Infection with Loa loa.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Annual Moxidectin Moxidectin Moxidectin 8mg per oral, administered annually for 24 months Biannual Ivermectin Ivermectin Ivermectin (approximately) 150 micrograms/kg per oral, administered biannually for 24 months Annual Ivermectin Ivermectin Ivermectin (approximately) 150 micrograms/kg per oral, administered annually for 24 months Biannual Moxidectin Moxidectin Moxidectin 8mg per oral, administered biannually for 24 months
- Primary Outcome Measures
Name Time Method Proportion of moxidectin annual and biannual recipients with sustained microfilarial response at month 12 Up to 12 months Proportion of recipients with zero Onchocerca volvulus microfilariae/mg skin at all post-treatment timepoints to month 12
Incidence and severity of adverse events Up to 36 months Incidence and severity of adverse events, vital signs and liver function tests
- Secondary Outcome Measures
Name Time Method Proportion of participants in all dose groups with sustained microfilariae response 6 months, 12 months, 18 months, 24 months, 30 months, 36 months Proportion of participants with zero Onchocerca volvulus microfilariae/mg skin
Sustained ocular microfilariae response in all dose groups 6 months, 12 months, 18 months, 24 months, 30 months, 36 months Proportion of participants with 0 live O. volvulus microfilariae in the anterior chambers of the eyes at all post-Baseline assessments in those with liver ocular microfilariae before the first treatment
Skin microfilarial density in all dose groups 6 months, 12 months, 18 months, 24 months, 30 months, 36 months Mean, median and percentage reduction Onchocerca volvulus microfilariae/mg skin from baseline
Ocular microfilariae response in all dose groups 6 months, 12 months, 18 months, 24 months, 30 months, 36 months Proportion of participants in all dose groups with 0 Onchocerca volvulus microfilariae/mg skin and 0 live microfilariae in the anterior chambers of the eyes each timepoint
Mean skin microfilariae density at each post-Screening assessment 6 months, 12 months, 18 months, 24 months, 30 months, 36 months Mean and mean change from baseline of Onchocerca volvulus microfilariae/mg skin
Trial Locations
- Locations (1)
Centre de Recherche pour les Maladies Tropicales Negligees
🇨🇩Rethy, Ituri, Congo, The Democratic Republic of the