Onchocerciasis Infections and Infestations Onchocerciasis
Conditions
Interventions
Single dose of moxidectin of 2 mg, 4 mg or 8 mg, or ivermectin at the approved dose.
Sponsors
UNICEF/UNDP/World Bank/WHO - Special Programme for Research and Training in Tropical Diseases (TDR)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Ivermectin-naïve men and women otherwise healthy, with O. volvulus infection 2. Informed consent 3. Aged 18 to 60 years 4. Body weight more than or equal to 40 kg for women, or more than or equal to 45 kg for men 5. Non-pregnant, non-lactating, willing to use contraception during the first 150 days after treatment 6. Normal medical history, physical examination, Electrocardiogram (ECG) and lab results 7. Adequate hematologic, renal and hepatic functions 8. Skin microfilarial density within the required range for the cohort
Exclusion criteria
Exclusion criteria: 1. Participation in any studies other than purely observational ones within four weeks before test article administration 2. Any vaccination within four weeks before test article administration 3. Acute infection requiring therapy within the last ten days before test article administration 4. Any medication (with the exception of medication required to treat any reactions during the screening fluorescein angiography (chlorpheniramine) or paracetamol) or herbal preparation within ten days prior to test article administration or any condition currently requiring regular medication 5. History of drug or alcohol abuse or regular use of more than three cigarettes/day, use of alcohol or other drugs of abuse within 72 hours before test article administration 6. Blood donation within eight weeks before study entry 7. Clinically significant ECG abnormalities, or history of cardiac abnormalities, or past or current history of neurological or neuropsychiatric disease or epilepsy 8. Ocular onchocerciasis 9. Hyperactive onchodermatitis 10. Antifilaria therapy within previous five years 11. Coincidental infection with Loa Loa 12. Orthostatic hypotension 13. Female patient with contraindication to DepoMedroxyProgesterone Acetate (DMPA) if not on Norplant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Data on safety and tolerability of a single oral dose of moxidectin (2, 4, or 8 mg) | — |
Secondary
| Measure | Time frame |
|---|---|
| Skin microfilaria levels up to 18 months post treatment | — |
Countries
Ghana
Outcome results
None listed