Overview

This trial is active, not recruiting.

Condition lymphatic filariasis
Treatments diethylcarbamazine, albendazole, ivermectin
Phase phase 2
Sponsor University Hospitals Cleveland Medical Center
Start date May 2014
End date December 2017
Trial size 182 participants
Trial identifier NCT01975441, CWRU 3 vs 2 LF ELIM PNG

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Diethylcarbamazine 6 mg/kg + Albendazole 400 mg administered annually (at 0, 12, and 24 months).
diethylcarbamazine DEC
Diethylcarbamazine 6mg/kg
albendazole ALB, Albenda
Albendazole 400mg
(Experimental)
Diethylcarbamazine 6 mg/kg + Albendazole 400 mg given once
diethylcarbamazine DEC
Diethylcarbamazine 6mg/kg
albendazole ALB, Albenda
Albendazole 400mg
(Experimental)
Diethylcarbamazine 6 mg/kg + Albendazole 400 mg + Ivermectin 200 µg/kg administered once only at the beginning of the RCT (0 month)
diethylcarbamazine DEC
Diethylcarbamazine 6mg/kg
albendazole ALB, Albenda
Albendazole 400mg
ivermectin IVM, Stromectol
Ivermectin 200 mcg/kg

Primary Outcomes

Measure
Percentage of subjects with total clearance of in Wuchereria bancrofti (Wb) microfilaria (mf)
time frame: at 36 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Men and women 18-65 years - >100mf/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+

Additional Information

Official title Evaluate Triple-Drug Therapy With Diethylcarbamize (DEC), Albendazole (ALB) and Ivermectin (IVM) That Could Accelerate LF Elimination Outside of Africa
Principal investigator Peter Siba, PhD
Description This will determine whether 1 or 2 annual treatments with the triple drug regimen of DEC/Iver/Alb is equally or more effective than repeated annual treatments with DEC/Alb in inducing sustained clearance of Mf in LF infected subjects previously determined to have >100Mf/ml, indicative of a moderate to heavy infection. Subjects will be treated and monitored in several common areas near study subject residences. 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).
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University Hospitals Cleveland Medical Center.