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Completed

NCT Number: NCT01975441

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

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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Key information

Conditions

Lymphatic Filariasis Elephantiasis, Filarial Filariasis Helminthiasis Hemic and Lymphatic Diseases Infections Lymphatic Diseases Lymphedema Mosquito-Borne Diseases Nematode Infections Parasitic Diseases Secernentea Infections Spirurida Infections Vector Borne Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Papua New Guinean Institute for Medical Research

Maprik, East Sepik Province, Papua New Guinea

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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+

Treatment and study plan

Diethylcarbamazine

Drug

Diethylcarbamazine 6mg/kg

Other names: DEC

Albendazole

Drug

Albendazole 400mg

Other names: ALB, Albenda

Ivermectin

Drug

Ivermectin 200 mcg/kg

Other names: IVM, Stromectol

Primary outcomes

  1. Percentage of subjects with total clearance of in Wuchereria bancrofti (Wb) microfilaria (mf)

    Time frame: at 36 months

Secondary outcomes

  1. Percentage of subjects with total clearance of Mf at 24 months.

    Time frame: 24 months

  2. Percent reduction in W. bancrofti antigen levels compared to baseline measured at 24 and 36 months

    Time frame: 24 months and 36 months

  3. 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

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Nov 4, 2013
Registry last updated
Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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