Eval 3-Drug Therapy Diethylcarbamize, Albendazole and Ivermectin That Could Accelerate LF Elimination Outside of Africa
Information source: University Hospital Case Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphatic Filariasis
Intervention: Diethylcarbamazine (Drug); Albendazole (Drug); Ivermectin (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University Hospital Case Medical Center Official(s) and/or principal investigator(s):
Peter Siba, PhD, Principal Investigator, Affiliation: Papua New Guinea Institution for Medical Research
Overall contact:
Christopher L King, MD, PhD, Phone: 4402476904, Email: cxk21@case.edu
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.
Clinical Details
Official title: Evaluate Triple-Drug Therapy With Diethylcarbamize (DEC), Albendazole (ALB) and Ivermectin (IVM) That Could Accelerate LF Elimination Outside of Africa
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Percentage of subjects with total clearance of in Wuchereria bancrofti (Wb) microfilaria (mf)
Detailed 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).
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Men and women 18-65 years
- >100mf/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+
Locations and Contacts
Christopher L King, MD, PhD, Phone: 4402476904, Email: cxk21@case.edu
Papua New Guinean Institute for Medical Research, Maprik, East Sepik, Papua New Guinea; Recruiting
James Suamani, Phone: +675 71066112, Email: jsuamani@gmail.com
Manasseh Baea, Phone: +675 73332320, Email: manasseh.baea@gmail.com
Additional Information
Starting date: October 2013
Last updated: October 28, 2013
|
