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

Lymphatic Filariasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01975441
• Other study ID #: CWRU 3 vs 2 LF ELIM PNG
• Status: Completed
• Phase: Phase 2
• Start date: May 2014
• Est. completion date: June 2018

Study information

• Verified date: October 2018
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: June 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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+

Related Conditions & MeSH terms

• Filariasis
• Lymphatic Filariasis

Intervention

Drug:
• Diethylcarbamazine
Diethylcarbamazine 6mg/kg
• Albendazole
Albendazole 400mg
• Ivermectin
Ivermectin 200 mcg/kg

Locations

Country	Name	City	State
Papua New Guinea	Papua New Guinean Institute for Medical Research	Maprik	East Sepik

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

Papua New Guinea, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects with total clearance of in Wuchereria bancrofti (Wb) microfilaria (mf)		at 36 months
Secondary	Percentage of subjects with total clearance of Mf at 24 months.		24 months
Secondary	Percent reduction in W. bancrofti antigen levels compared to baseline measured at 24 and 36 months		24 months and 36 months
Secondary	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