Eval 3-Drug Therapy Diethylcarbamize, Albendazole and Ivermectin That Could Accelerate LF Elimination Outside of Africa
- Conditions
- Lymphatic Filariasis
- Interventions
- Registration Number
- NCT01975441
- Lead Sponsor
- University Hospitals Cleveland Medical Center
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 182
- Men and women 18-65 years
- >50 mf/ml in finger stick blood samples
- Willing to give informed consent
- 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+
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description standard treatment Diethylcarbamazine Diethylcarbamazine 6 mg/kg + Albendazole 400 mg administered annually (at 0, 12, and 24 months). standard treatment Albendazole Diethylcarbamazine 6 mg/kg + Albendazole 400 mg administered annually (at 0, 12, and 24 months). DEC 6 mg/kg + Alb 400 mg x 1 Diethylcarbamazine Diethylcarbamazine 6 mg/kg + Albendazole 400 mg given once DEC 6 mg/kg + Alb 400 mg x 1 Albendazole Diethylcarbamazine 6 mg/kg + Albendazole 400 mg given once DEC + ALB + IVM Ivermectin Diethylcarbamazine 6 mg/kg + Albendazole 400 mg + Ivermectin 200 µg/kg administered once only at the beginning of the RCT (0 month) DEC + ALB + IVM Diethylcarbamazine Diethylcarbamazine 6 mg/kg + Albendazole 400 mg + Ivermectin 200 µg/kg administered once only at the beginning of the RCT (0 month) DEC + ALB + IVM Albendazole Diethylcarbamazine 6 mg/kg + Albendazole 400 mg + Ivermectin 200 µg/kg administered once only at the beginning of the RCT (0 month)
- Primary Outcome Measures
Name Time Method Percentage of subjects with total clearance of in Wuchereria bancrofti (Wb) microfilaria (mf) at 36 months
- Secondary Outcome Measures
Name Time Method Percentage of subjects with total clearance of Mf at 24 months. 24 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 Percent reduction in W. bancrofti antigen levels compared to baseline measured at 24 and 36 months 24 months and 36 months
Trial Locations
- Locations (1)
Papua New Guinean Institute for Medical Research
🇵🇬Maprik, East Sepik, Papua New Guinea