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

University Hospitals (UH)

Status and phase: Completed; Phase 2

Conditions: Lymphatic Filariasis

Treatments: Drug: Albendazole; Drug: Diethylcarbamazine; Drug: Ivermectin

Study type: Interventional

Funder types: Other

Identifiers

NCT01975441

CWRU 3 vs 2 LF ELIM PNG

Details and patient eligibility

About

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.

Full 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:

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

Enrollment: 182 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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+

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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182 participants in 3 patient groups

standard treatment

Active Comparator group

Description:

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

Treatment:

Drug: Diethylcarbamazine

Drug: Albendazole

DEC 6 mg/kg + Alb 400 mg x 1

Experimental group

Description:

Diethylcarbamazine 6 mg/kg + Albendazole 400 mg given once

Treatment:

Drug: Diethylcarbamazine

Drug: Albendazole

DEC + ALB + IVM

Experimental group

Description:

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

Treatment:

Drug: Ivermectin

Drug: Diethylcarbamazine

Drug: Albendazole