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