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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2018-06-30

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.

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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:

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).

Conditions

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Lymphatic Filariasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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standard treatment

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

Group Type ACTIVE_COMPARATOR

Diethylcarbamazine

Intervention Type DRUG

Diethylcarbamazine 6mg/kg

Albendazole

Intervention Type DRUG

Albendazole 400mg

DEC 6 mg/kg + Alb 400 mg x 1

Diethylcarbamazine 6 mg/kg + Albendazole 400 mg given once

Group Type EXPERIMENTAL

Diethylcarbamazine

Intervention Type DRUG

Diethylcarbamazine 6mg/kg

Albendazole

Intervention Type DRUG

Albendazole 400mg

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)

Group Type EXPERIMENTAL

Diethylcarbamazine

Intervention Type DRUG

Diethylcarbamazine 6mg/kg

Albendazole

Intervention Type DRUG

Albendazole 400mg

Ivermectin

Intervention Type DRUG

Ivermectin 200 mcg/kg

Interventions

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Diethylcarbamazine

Diethylcarbamazine 6mg/kg

Intervention Type DRUG

Albendazole

Albendazole 400mg

Intervention Type DRUG

Ivermectin

Ivermectin 200 mcg/kg

Intervention Type DRUG

Other Intervention Names

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DEC ALB, Albenda IVM, Stromectol

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+

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes