NCT02078024

Efficacy of Ivermectin and Albendazole Against Onchocerciasis in the Volta Region, Ghana

Comparison of Ivermectin Alone With Albendazole (ALB) Plus Ivermectin (IVM) in Their Efficacy Against Onchocerciasis in the Volta Region, Ghana.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 375 (estimated)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

We will examine whether a combination of Ivermectim (IVM) plus Albendazole (ALB) compared to IVM alone given annually, which is the current standard for mass drug administration (MDA), is more effective in sterilizing adult worms. We will also address whether IVM plus ALB given twice per year is superior to IVM given once per year or twice per year.

Detailed description

We hypothesize that more effective combinations of dose schedules of existing antifilarial drugs for MDA against onchocerciasis could shorten the number of years needed to interrupt onchocerciasis transmission and eliminate this infectious disease in areas that previously had high disease rates. Improved treatments should also make it feasible to extend MDA into areas that are currently not being helped. These changes have the potential to completely change the game to make global elimination of onchocerciasis a feasible goal. Participants will be randomized into 5 treatment arms with 75 subjects in each arm for a total of 375 and followed for 36 months after the initial treatment. The primary endpoint will be the percent fertile adult female worms in nodules removed 36 months after the initiation of treatment.

Conditions

• Onchocerciasis

Interventions

Type	Name	Description
DRUG	IVM plus ALB
DRUG	IVM

Timeline

• Start date: 2014-06-01
• Primary completion: 2018-06-01
• Completion: 2018-06-25
• First posted: 2014-03-04
• Last updated: 2019-04-26

Locations

1 site across 1 country: Ghana