Eval 3-Drug Therapy Diethylcarbamize, Albendazole and Ivermectin That Could Accelerate LF Elimination Outside of Africa
This trial is active, not recruiting.
|Treatments||diethylcarbamazine, albendazole, ivermectin|
|Sponsor||University Hospitals Cleveland Medical Center|
|Start date||May 2014|
|End date||December 2017|
|Trial size||182 participants|
|Trial identifier||NCT01975441, CWRU 3 vs 2 LF ELIM PNG|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
Percentage of subjects with total clearance of in Wuchereria bancrofti (Wb) microfilaria (mf)
time frame: at 36 months
Male or female participants from 18 years up to 65 years old.
- Men and women 18-65 years
- >100mf/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+
|Official title||Evaluate Triple-Drug Therapy With Diethylcarbamize (DEC), Albendazole (ALB) and Ivermectin (IVM) That Could Accelerate LF Elimination Outside of Africa|
|Principal investigator||Peter Siba, PhD|
|Description||This will determine whether 1 or 2 annual treatments with the triple drug regimen of DEC/Iver/Alb is equally or more effective than repeated annual treatments with DEC/Alb in inducing sustained clearance of Mf in LF infected subjects previously determined to have >100Mf/ml, indicative of a moderate to heavy infection. Subjects will be treated and monitored in several common areas near study subject residences. 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).|
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