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Ivermectin--clinical trials and treatment schedules in onchocerciasis
Abstract:
Initial clinical trials with ivermectin were performed in patients with both roundworm infestation and onchocerciasis. Obvious clinical safety allowed for rapid progression through 5-30-50-100-150-200 mcg/kg in infected patients. Initial studies showed some effect at 50 mcg/kg; subsequent double-blind controlled studies, either with placebo or diethylcarbamazine (DEC), confirmed the efficacy of ivermectin as well as further defining its safety profile. Absence of adverse eye findings or serious systemic reactions justified the further open trials. Studies of patients treated at 6, 12, or 18 month intervals showed a long lasting effect of ivermectin in reducing skin microfilaria counts. Phase III studies confirmed safety and efficacy and further refined the dose to 150 mcg/kg every 12 months. Large trials in Liberia and other countries in West Africa, and subsequently under Onchocerciasis Control Program (OCP), included approximately 120,000 persons carefully followed during which few patients with serious adverse experiences were reported. These extensive field trials confirmed the relative safety allowing for broad distribution of ivermectin in programs not able to provide physician monitoring.
Insights
Ivermectin demonstrates excellent safety and efficacy for treating roundworm infestation and onchocerciasis. Clinical trials confirm its effectiveness, supporting widespread use in public health programs.
Area of Science:
- Parasitology
- Clinical Pharmacology
- Tropical Medicine
Background:
- Ivermectin was initially investigated for parasitic infections.
- Early trials focused on safety and dosage escalation in infected patients.
Purpose of the Study:
- To evaluate the safety and efficacy of ivermectin in treating roundworm infestation and onchocerciasis.
- To determine optimal dosing and long-term effects of ivermectin therapy.
Main Methods:
- Initial dose-ranging studies (5-200 mcg/kg) in infected patients.
- Double-blind, placebo-controlled, and diethylcarbamazine (DEC)-controlled trials.
- Open-label trials and large-scale field studies (approx. 120,000 participants) in West Africa under the Onchocerciasis Control Program (OCP).
Main Results:
- Ivermectin showed efficacy at 50 mcg/kg, with optimal dosing refined to 150 mcg/kg every 12 months.
- Demonstrated long-lasting reduction in skin microfilaria counts.
- Extensive field trials confirmed ivermectin's relative safety, with few serious adverse experiences reported.
Conclusions:
- Ivermectin is a safe and effective treatment for onchocerciasis and roundworm infestation.
- The established safety profile supports broad distribution in public health programs, even without physician monitoring.