Clinical trial NCT01975441: Eval 3-Drug Therapy Diethylcarbamize, Albendazole and Ivermectin That Could Accelerate LF Elimination Outside of Africa
Official title: Evaluate Triple-Drug Therapy With Diethylcarbamize (DEC), Albendazole (ALB) and Ivermectin (IVM) That Could Accelerate LF Elimination Outside of Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphatic Filariasis
Keywords: Diethycarbamazine
Albendazole
Ivermectin
Lymphatic filariasis
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2013-11-03
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility 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+

Primary outcomes:
measure: Percentage of subjects with total clearance of in Wuchereria bancrofti (Wb) microfilaria (mf)
timeFrame: at 36 months
Secondary outcomes:
measure: Percentage of subjects with total clearance of Mf at 24 months.
timeFrame: 24 months
measure: Percent reduction in W. bancrofti antigen levels compared to baseline measured at 24 and 36 months
timeFrame: 24 months and 36 months
measure: Percent of subjects who become circulating antigen negative at 24 months and 36 months after the beginning of the study
timeFrame: 24 months and 36 months
Other outcomes:
Locations:
city: Maprik
country: Papua New Guinea
facility: Papua New Guinean Institute for Medical Research
state: East Sepik
Study officials:
affiliation: Papua New Guinea Institution for Medical Research
name: Peter Siba, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.