Overview
Effect of Albendazole Dose on Clearance of Filarial Worms
Status:
Completed
Completed
Trial end date:
2011-08-17
2011-08-17
Target enrollment:
0
0
Participant gender:
All
All
Summary
This study, conducted in Mali, West Africa, will determine whether a new treatment regimen for lymphatic filariasis can eliminate the disease more quickly than the standard regimen. Lymphatic filariasis is caused by infection with very small filarial worms called Wuchereria bancrofti that are spread by mosquitoes. The disease can cause swelling of the arms, legs, breast and genitalia and can progress to permanent swelling of the legs or arms called elephantiasis. Currently, patients in Mali are treated with a single dose of 400 mg of albendazole plus two doses of 200 mcg/kg of ivermectin each year. This study will use a regimen of 800 mg of albendazole twice a year plus 200 mcg/kg of ivermectin twice a year for 2 years. The study will see if the new regimen is more effective in lowering the numbers of Wuchereria bancrofti in the blood and will examine the effects of the two treatments on the adult worms living in the lymph system. Healthy people between 14 and 65 years of age who live in the Mali village of N'Tessoni and are infected with Wuchereria bancrofti may be eligible for this study. Candidates are screened with a medical history, a brief physical examination and blood tests to check for infection with Wuchereria bancrofti and to measure white blood cell counts. Participants undergo the following procedures: -First visit Ultrasound examination to look for filarial worms in the body. Random assignment to receive either standard treatment or the experimental regimen Urine pregnancy test for women of child-bearing age. Receive first treatment dose. -6-month visit Short history, physical examination and blood test. Second treatment dose for subjects in experimental treatment group. Urine pregnancy test for women of childbearing age. -1-year visit Short history, physical examination and blood test. Second or third treatment dose, depending on treatment group. Repeat ultrasound in subjects whose first ultrasound detected adult worms. Urine pregnancy test for women of childbearing age. -18-month visit Short history, physical examination and blood test. Fourth treatment dose for subjects in experimental treatment group. Urine pregnancy test for women of childbearing age. -24-month visit Short history, physical examination and blood test. Repeat ultrasound in subjects whose first ultrasound detected adult worms. Urine pregnancy test for women of childbearing age.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)Treatments:
Albendazole
Ivermectin
Criteria
- INCLUSION CRITERIA (Screening):- age 14 to 65.
- men and women*.
- Please note: women are not permitted to leave their homes at night without the
approval of their husband or, if they are not married, a parent or male guardian.
Since this protocol involves blood drawing at night, such approval is necessary
for participation.
EXCLUSION CRITERIA (Screening):
- non-volunteers.
- age less than 14 or greater than 65.
- pregnant by history.
INCLUSION CRITERIA (Treatment):
- age 14 to 65 years.
- men and women.*
- Wb microfilarial count greater than or equal to 50 mf/ml.
EXCLUSION CRITERIA (Treatment):
- non-volunteers.
- age less than 14 or greater than 65.
- pregnancy.
- Hgb less than 9 g/dl.
- Heavy alcohol use (more than 7 beer or other alcohol-containing drink/week).
- Temperature greater than 37.5C or other serious medical illnesses.
- history of benzimidazole allergy.
- history of ivermectin allergy.
- use of albendazole or ivermectin within the past 6 months.