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Safety and Efficacy of Novel Combination Regimens for Treatment of Onchocerciasis

Onchocerciasis Clinical Trial

Official title:
Safety and Efficacy of Novel Combination Regimens for Treatment of Onchocerciasis

Clinical Trial Summary

This study will investigate the safety and effectiveness of combination regimens in persons with onchocerciasis when it is administered after pre-treatment with ivermectin to clear or greatly reduce microfilariae from the skin and eyes.

Clinical Trial Description

The open label, randomized clinical trial studies the safety and efficacy of combination regimens for the treatment of onchocerciasis. Around 300 participants from Bong Mines, Liberia will be randomly assigned to one of four treatment groups after receiving Ivermectin pre-treatment: Ivermectin plus Albendazole (IA0, Ivermectin plus DEC plus Albendazole (IDA), Moxidectin plus albendazole (MoxA), or Moxidectin plus DEC plus Albendazole (MoxDA). Participants will be treated at baseline and 6 months after initial treatment. Safety will be measured through extensive adverse event monitoring from baseline to 6 months. Efficacy of the treatment will be measured at 24 months after the initial treatment by the proportion of all adult female worms that are fertile in the Onchocerca nodules and the percentage of participants without microfilaremia at 6, 18, and 24 months after the first treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06070116
Study type Interventional
Source Washington University School of Medicine
Contact
Status Enrolling by invitation
Phase Phase 2
Start date April 5, 2024
Completion date September 1, 2026
View Details
See also
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