Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01975441
Recruitment Status : Completed
First Posted : November 4, 2013
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Christopher L. King, MD, PhD, University Hospitals Cleveland Medical Center

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:

  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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 2014
Actual Primary Completion Date : December 2017
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


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 Name: DEC

Drug: Albendazole
Albendazole 400mg
Other Name: 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 Name: DEC

Drug: Albendazole
Albendazole 400mg
Other Name: 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 Name: DEC

Drug: Albendazole
Albendazole 400mg
Other Name: ALB, Albenda

Drug: Ivermectin
Ivermectin 200 mcg/kg
Other Name: IVM, Stromectol




Primary Outcome Measures :
  1. Percentage of subjects with total clearance of in Wuchereria bancrofti (Wb) microfilaria (mf) [ Time Frame: at 36 months ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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+

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01975441


Locations
Layout table for location information
Papua New Guinea
Papua New Guinean Institute for Medical Research
Maprik, East Sepik, Papua New Guinea
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Peter Siba, PhD Papua New Guinea Institution for Medical Research

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Christopher L. King, MD, PhD, Professor/PI, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT01975441     History of Changes
Other Study ID Numbers: CWRU 3 vs 2 LF ELIM PNG
First Posted: November 4, 2013    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Keywords provided by Christopher L. King, MD, PhD, University Hospitals Cleveland Medical Center:
Diethycarbamazine
Albendazole
Ivermectin
Lymphatic filariasis
Additional relevant MeSH terms:
Layout table for MeSH terms
Filariasis
Elephantiasis, Filarial
Elephantiasis
Spirurida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Lymphedema
Lymphatic Diseases
Ivermectin
Albendazole
Diethylcarbamazine
Antiparasitic Agents
Anti-Infective Agents
Anthelmintics
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Filaricides
Antinematodal Agents
Lipoxygenase Inhibitors
Enzyme Inhibitors