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

Sponsor

University Hospitals Cleveland Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01975441

Collaborator

(none)

182

Enrollment

Location

Arms

Actual Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphatic Filariasis	Drug: Diethylcarbamazine Drug: Albendazole Drug: Ivermectin	Phase 2

Detailed Description

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

182 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2014

Actual Primary Completion Date :

Dec 1, 2017

Actual Study Completion Date :

Jun 1, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: standard treatment

Diethylcarbamazine 6 mg/kg + Albendazole 400 mg administered annually (at 0, 12, and 24 months).

Drug: Diethylcarbamazine

Diethylcarbamazine 6mg/kg

Other Names:

DEC

Drug: Albendazole

Albendazole 400mg

Other Names:

ALB, Albenda

Experimental: DEC 6 mg/kg + Alb 400 mg x 1

Diethylcarbamazine 6 mg/kg + Albendazole 400 mg given once

Drug: Diethylcarbamazine

Diethylcarbamazine 6mg/kg

Other Names:

DEC

Drug: Albendazole

Albendazole 400mg

Other Names:

ALB, Albenda

Experimental: DEC + ALB + IVM

Diethylcarbamazine 6 mg/kg + Albendazole 400 mg + Ivermectin 200 µg/kg administered once only at the beginning of the RCT (0 month)

Drug: Diethylcarbamazine

Diethylcarbamazine 6mg/kg

Other Names:

DEC

Drug: Albendazole

Albendazole 400mg

Other Names:

ALB, Albenda

Drug: Ivermectin

Ivermectin 200 mcg/kg

Other Names:

IVM, Stromectol

Outcome Measures

Primary Outcome Measures

Percentage of subjects with total clearance of in Wuchereria bancrofti (Wb) microfilaria (mf) [at 36 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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+