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

Evaluate Triple-Drug Therapy With Diethylcarbamize (DEC), Albendazole (ALB) and Ivermectin (IVM) That Could Accelerate LF Elimination Outside of Africa

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01975441

Enrollment

182

Registered

2013-11-04

Start date

2014-05-31

Completion date

2018-06-30

Last updated

2018-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphatic Filariasis

Keywords

Diethycarbamazine, Albendazole, Ivermectin, Lymphatic filariasis

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).

Interventions

DRUGDiethylcarbamazine

Diethylcarbamazine 6mg/kg

DRUGAlbendazole

Albendazole 400mg

DRUGIvermectin

Ivermectin 200 mcg/kg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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+

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Papua New Guinea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026