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

NCT01975441 | Completed Phase 2 DMC

• 1 other identifier: CWRU 3 vs 2 LF ELIM PNG
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphatic Filariasis

Keywords

Diethycarbamazine; Albendazole; Ivermectin; Lymphatic filariasis

Outcome Measures

Primary Outcomes (1)

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

  at 36 months

Secondary Outcomes (3)

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

  24 months

• Percent reduction in W. bancrofti antigen levels compared to baseline measured at 24 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

  24 months and 36 months

Study Arms (3)

standard treatment

ACTIVE COMPARATOR

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

Drug: Diethylcarbamazine; Drug: Albendazole

DEC 6 mg/kg + Alb 400 mg x 1

EXPERIMENTAL

Diethylcarbamazine 6 mg/kg + Albendazole 400 mg given once

Drug: Diethylcarbamazine; Drug: Albendazole

DEC + ALB + IVM

EXPERIMENTAL

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

Drug: Diethylcarbamazine; Drug: Albendazole; Drug: Ivermectin

Interventions

Diethylcarbamazine DRUG

Diethylcarbamazine 6mg/kg

Also known as: DEC

DEC + ALB + IVM; DEC 6 mg/kg + Alb 400 mg x 1; standard treatment

Albendazole DRUG

Albendazole 400mg

Also known as: ALB, Albenda

DEC + ALB + IVM; DEC 6 mg/kg + Alb 400 mg x 1; standard treatment

Ivermectin DRUG

Ivermectin 200 mcg/kg

Also known as: IVM, Stromectol

DEC + ALB + IVM

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women 18-65 years
• \>50 mf/ml in finger stick blood samples
• Willing to give informed consent

You may not qualify if:

• 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+

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

Papua New Guinean Institute for Medical Research

Maprik, East Sepik Province, Papua New Guinea

Location

Related Publications (2)

• King CL, Suamani J, Sanuku N, Cheng YC, Satofan S, Mancuso B, Goss CW, Robinson LJ, Siba PM, Weil GJ, Kazura JW. A Trial of a Triple-Drug Treatment for Lymphatic Filariasis. N Engl J Med. 2018 Nov 8;379(19):1801-1810. doi: 10.1056/NEJMoa1706854.

  PMID: 30403937 DERIVED

• Thomsen EK, Sanuku N, Baea M, Satofan S, Maki E, Lombore B, Schmidt MS, Siba PM, Weil GJ, Kazura JW, Fleckenstein LL, King CL. Efficacy, Safety, and Pharmacokinetics of Coadministered Diethylcarbamazine, Albendazole, and Ivermectin for Treatment of Bancroftian Filariasis. Clin Infect Dis. 2016 Feb 1;62(3):334-341. doi: 10.1093/cid/civ882. Epub 2015 Oct 20.

  PMID: 26486704 DERIVED

MeSH Terms

Conditions

Elephantiasis, Filarial

Interventions

Diethylcarbamazine; Albendazole; Albumins; Ivermectin; Intravital Microscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Proteins; Amino Acids, Peptides, and Proteins; Macrolides; Polyketides; Lactones; Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Peter Siba, PhD

  Papua New Guinea Institution for Medical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor/PI

Study Record Dates

• First Submitted: October 28, 2013
• First Posted: November 4, 2013
• Study Start: May 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: June 1, 2018
• Last Updated: October 9, 2018

Record last verified: 2018-10

Locations

PA (1)