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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01975441
• Date of registration: 28/10/2013
• Prospective Registration: Yes
• Primary sponsor: University Hospitals Cleveland Medical Center
• Public title: Eval 3-Drug Therapy Diethylcarbamize, Albendazole and Ivermectin That Could Accelerate LF Elimination Outside of Africa
• Scientific title: Evaluate Triple-Drug Therapy With Diethylcarbamize (DEC), Albendazole (ALB) and Ivermectin (IVM) That Could Accelerate LF Elimination Outside of Africa
• Date of first enrolment: May 2014
• Target sample size: 182
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01975441
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Papua New Guinea

Contacts

• Name: Peter Siba, PhD
• Affiliation: Papua New Guinea Institution for Medical Research

Key inclusion & exclusion 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+



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Lymphatic Filariasis

Intervention(s)

Drug: Ivermectin

Drug: Albendazole

Drug: Diethylcarbamazine

Primary Outcome(s)

Percentage of subjects with total clearance of in Wuchereria bancrofti (Wb) microfilaria (mf) [Time Frame: at 36 months]

Secondary Outcome(s)

Percent of subjects who become circulating antigen negative at 24 months and 36 months after the beginning of the study [Time Frame: 24 months and 36 months]

Percentage of subjects with total clearance of Mf at 24 months. [Time Frame: 24 months]

Percent reduction in W. bancrofti antigen levels compared to baseline measured at 24 and 36 months [Time Frame: 24 months and 36 months]

Secondary ID(s)

CWRU 3 vs 2 LF ELIM PNG

Source(s) of Monetary Support

Please refer to primary and secondary sponsors