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

October 5, 2018 updated by: Christopher L. King, MD, PhD, University Hospitals Cleveland Medical Center

Evaluate Triple-Drug Therapy With Diethylcarbamize (DEC), Albendazole (ALB) and Ivermectin (IVM) 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  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).

Study Type

Interventional

Enrollment (Actual)

182

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Papua New Guinea
    • East Sepik
      • Maprik, East Sepik, Papua New Guinea
        • Papua New Guinean Institute for Medical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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+

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Cleveland Medical Center

Investigators

  • Principal Investigator: Peter Siba, PhD, Papua New Guinea Institution for Medical Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2014

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

October 28, 2013

First Submitted That Met QC Criteria

October 28, 2013

First Posted (Estimate)

November 3, 2013

Study Record Updates

Last Update Posted (Actual)

October 9, 2018

Last Update Submitted That Met QC Criteria

October 5, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CWRU 3 vs 2 LF ELIM PNG

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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