A Phase 2 interventional study of Diethylcarbamazine and Albendazole in Lymphatic Filariasis, sponsored by University Hospitals Cleveland Medical Center. Completed at 1 site in Papua New Guinea. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-09.
Sponsored by University Hospitals Cleveland Medical Center · Phase 2, Interventional, and Treatment
This study will determine if a combination of 3 drugs used to treat the infection that cause lymphatic filariasis (LF) due to Wuchereria bancrofti infection are more effective in killing or sterilizing the adult worms compared to just 2 of the 3 drugs that usually given to treat this infection. The three drugs used together are called albendazole (ALB), ivermectin (IVM) and diethylcarbamazine (DEC). The usual treatment in Papua New Guinea (PNG) for lymphatic filariasis are DEC and ALB. A combination of these 3 drugs has not been previously used to treat LF.
This study will determine whether a single dose of the triple drug regimen of DEC/Iver/Alb is non-inferior to annual treatments with DEC/Alb in inducing sustained clearance of Mf in LF infected subjects (>50 Mf/ml) at 36 months post-treatment. This study also tests the hypothesis that single dose of triple drug is super in sustained clearance of microfilariae compared to single dose of DEC/ALB.
There will be 3 treatment arms as follows:
Exclusion Criteria:
Diethylcarbamazine 6 mg/kg + Albendazole 400 mg administered annually (at 0, 12, and 24 months).
Drug: Diethylcarbamazine · Drug: Albendazole
Diethylcarbamazine 6 mg/kg + Albendazole 400 mg given once
Drug: Diethylcarbamazine · Drug: Albendazole
Diethylcarbamazine 6 mg/kg + Albendazole 400 mg + Ivermectin 200 µg/kg administered once only at the beginning of the RCT (0 month)
Drug: Diethylcarbamazine · Drug: Albendazole · Drug: Ivermectin
Diethylcarbamazine 6mg/kg
Also known as: DEC
Albendazole 400mg
Also known as: ALB, Albenda
Ivermectin 200 mcg/kg
Also known as: IVM, Stromectol
Percentage of subjects with total clearance of in Wuchereria bancrofti (Wb) microfilaria (mf)
Time frame: at 36 months
Percentage of subjects with total clearance of Mf at 24 months.
Time frame: 24 months
Percent reduction in W. bancrofti antigen levels compared to baseline measured at 24 and 36 months
Time frame: 24 months and 36 months
Percent of subjects who become circulating antigen negative at 24 months and 36 months after the beginning of the study
Time frame: 24 months and 36 months
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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University Hospitals Cleveland Medical Center