Eval 3-Drug Therapy Diethylcarbamize, Albendazole and Ivermectin That Could Accelerate LF Elimination Outside of Africa

Study Overview
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Brief Summary
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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.

Detailed Description
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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: The comparator (standard treatment) DEC 6 mg/kg + Alb 400 mg administered annually (at 0, 12, and 24 months). DEC 6 mg/kg + Alb 400 mg given once DEC 6 mg/kg + Alb 400 mg + Iver 200 µg/kg administered once only at the beginning of the RCT (0 month).

Official Title
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Evaluate Triple-Drug Therapy With Diethylcarbamize (DEC), Albendazole (ALB) and Ivermectin (IVM) That Could Accelerate LF Elimination Outside of Africa

Conditions
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Lymphatic Filariasis

Intervention / Treatment
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* Drug: Diethylcarbamazine
* Drug: Albendazole
* Drug: Ivermectin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women 18-65 years >50 mf/ml in finger stick blood samples Willing to give informed consent Exclusion Criteria: Prior treatment for LF within last 5 years Pregnant (do pregnancy test) Hemoglobin < 7 g/dl permanent disability, serious medical illness that prevents or impedes study participation and/or comprehension AST/ALT and creatinine > 1.5 upper limit of normal. Urine dipstick with glucose ≥ 2+ and/or protein ≥ 2+

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard treatment<br>Diethylcarbamazine 6 mg/kg + Albendazole 400 mg administered annually (at 0, 12, and 24 months). | Drug: Diethylcarbamazine<br>* Diethylcarbamazine 6mg/kg<br>* Other names: DEC;Drug: Albendazole<br>* Albendazole 400mg<br>* Other names: ALB, Albenda;|
| Experimental: DEC 6 mg/kg + Alb 400 mg x 1<br>Diethylcarbamazine 6 mg/kg + Albendazole 400 mg given once | Drug: Diethylcarbamazine<br>* Diethylcarbamazine 6mg/kg<br>* Other names: DEC;Drug: Albendazole<br>* Albendazole 400mg<br>* Other names: ALB, Albenda;|
| Experimental: DEC + ALB + IVM<br>Diethylcarbamazine 6 mg/kg + Albendazole 400 mg + Ivermectin 200 µg/kg administered once only at the beginning of the RCT (0 month) | Drug: Diethylcarbamazine<br>* Diethylcarbamazine 6mg/kg<br>* Other names: DEC;Drug: Albendazole<br>* Albendazole 400mg<br>* Other names: ALB, Albenda;Drug: Ivermectin<br>* Ivermectin 200 mcg/kg<br>* Other names: IVM, Stromectol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with total clearance of in Wuchereria bancrofti (Wb) microfilaria (mf) |  | at 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with total clearance of Mf at 24 months. |  | 24 months | 
| Percent reduction in W. bancrofti antigen levels compared to baseline measured at 24 and 36 months |  | 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 |  | 24 months and 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diethycarbamazine, Albendazole, Ivermectin, Lymphatic filariasis