Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00339417
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-06-19
Brief Title:
Effect of Albendazole Dose on Clearance of Filarial Worms
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Effect of Albendazole and Ivermectin Dose on Wuchereria Bancrofti Microfilarial Clearance in Mali A Randomized Open Label Study
Status:
COMPLETED
Status Verified Date:
2011-08-17
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 mcgkg of ivermectin each year This study will use a regimen of 800 mg of albendazole twice a year plus 200 mcgkg 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 NTessoni 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
Healthy people between 14 and 65 years of age who live in the Mali village of NTessoni 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
Detailed Description:
Albendazole and ivermectin are currently used in combination for annual mass treatment of lymphatic filariasis in Africa Although the drugs have been donated the cost of such programs is very high and has proven to be a major impediment to the success of programs in many countries with limited financial resources Data from albendazole treatment of other filarial infections and one study comparing single to multi-dose DECalbendazole in lymphatic filariasis suggest that increased dose andor frequency of albendazole dosing may be more effective in clearing microfilariae Furthermore the optimal dose of ivermectin for the treatment of lymphatic filariasis is greater than that being used in the current mass treatment program In this study 50 volunteers with microfilaremic Wuchereria bancrofti infection will be randomized to receive standard annual therapy albendazole 400 mg ivermectin 150 mcgkg or semiannual therapy with an increased albendazole dose albendazole 800 mg ivermectin 400 mcgkg If adequate numbers of microfilaremic subjects are recruited an additional 25 volunteers will receive annual therapy with the increased dose combination Microfilarial levels as well as measures of adult worm burden circulating antigen ultrasound identification of adult worm nests will be followed every six months for three years to assess the effects of the treatments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-I-N107 | None | None | None |