Clinical trial NCT00511004
Conditions: Lymphatic Filariasis
Keywords: Brugia Malayi Lymphatic Filariasis Albendazole Diethylcarbamazine
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Start date: 2007-07-01; Completion date: 2014-02-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is conducted in Kerala, India. It will determine whether a new treatment regimen of albendazole and diethylcarbamazine (DEC) for lymphatic filariasis can eliminate the disease more quickly than the standard regimen. Lymphatic filariasis is caused by infection with very small parasitic worms that are spread by mosquitoes. The disease can cause swelling of the arms, legs, breast and scrotum and can progress to permanent swelling of the legs or arms called elephantiasis. The study will see if a higher and more frequent dose of albendazole is better at clearing filarial worms from the blood than the current treatment.

Healthy people between 18 and 55 years of age who are in good health and who are infected with filarial worms may be eligible for this study.

Participants undergo the following procedures:

3-day hospital stay at the Filariasis Chemotherapy Unit of the T.D. Medical College Hospital in Kerala, India

* Random assignment to receive either: 400 mg albendazole and DEC 300 mg given once a year for 2 years (standard treatment); or 800 mg albendazole and DEC 300 mg given once a year for 2 years; or 800 mg albendazole and DEC 300 mg given twice a year for 2 years.
* Urine pregnancy test for women of childbearing age .
* Ultrasound test to look for filarial worms.
* Treatment dose.
* Monitoring for symptoms

  6-month 3-day hospital stay
* Medical history, physical examination and blood test.
* Repeat ultrasound in subjects whose first ultrasound detected adult worms.
* Treatment dose for subjects receiving medicine every 6 months.
* Urine pregnancy test for women of childbearing age.

  1-year 3-day hospital stay
* Medical history, physical examination and blood test.
* Treatment dose.
* Repeat ultrasound in subjects whose first ultrasound detected adult worms.
* Urine pregnancy test for women of childbearing age.

  18-month 3-day hospital stay
* Medical history, physical examination and blood test.
* Treatment dose for subjects receiving medicine every 6 months.
* Urine pregnancy test for women of childbearing age.

  24-month 3-day hospital stay
* Medical history, physical examination and blood test.
* Treatment dose.
* Repeat ultrasound in subjects whose first ultrasound detected adult worms.
* Urine pregnancy test for women of childbearing age.

Detailed description:
Albendazole and diethylcarbamazine (DEC) are currently used in combination for annual mass treatment of lymphatic filariasis in all parts of the world except 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 DEC/albendazole in lymphatic filariasis suggest that increased dose and/or frequency of albendazole dosing may be more effective in clearing microfilariae. In this study, 75 volunteers with microfilaremic Brugia malayi infection will be randomized to receive standard annual therapy (albendazole 400 mg + DEC 300 mg), annual therapy with increased dosing of albendazole (albendazole 800 mg + DEC 300 mg), or semiannual therapy with an increased albendazole dose (albendazole 800 mg + DEC 300 mg). Microfilarial levels will be followed every 6 months for 2 years to determine whether the higher dose, and/or the more frequent regimen, is more effective.

Arms: arm 1: Standard therapy of DEC (300mg) and albendazole (400mg) yearly arm 2: High dose of DEC (300mg) and albendazole (800mg) yearly arm 3: High dose of DEC (300mg) and albendazole (800mg) twice yearly (every 6 months)
Interventions: intervention 1: Albendazole intervention 2: Diethylcarbamazine
Intervention descriptions: intervention 1: Comparing 400 mg to 800 mg dose intervention 2: Providing diethylcarbamazine more frequently in combination with albendazole

Protocol documents: