Clinical Trial: Effect of Albendazole Dose on Treatment of Lymphatic Filariasis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Effect of Albendazole Dose and Interval on Brugia Malayi Microfilarial Clearance in India: A Randomized, Open Label Study
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.
- Adult Worm Burdens at 2 Years [ Time Frame: 2 years from the time enrolled. ]Doppler detected worm nests at 2 years
- Microfilarial Levels at 2 Years [ Time Frame: 2 years from time enrolled ]Night time microfilarial levels at 2 years
- Brugia Specific Immunoglobulin G4 (IgG4) Antibodies [ Time Frame: 2 years ]IgG4 antibodies directed against Brugia malayi antigen
Detailed Summary: 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.
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Current Primary Outcome: Microfilarial Counts at 1 Year [ Time Frame: 1 year from time enrolled ]
Original Primary Outcome: To determine whether increasing the albendazole dose or the frequency of treatment with DEC/albendazole is mor effective than the current proved mass treatment regimen at clearing microfilaremia as assessed by microfilarial counts at one year.
Current Secondary Outcome:
Original Secondary Outcome: To assess effect on adult worm burdens, microfilariae at 2 yeard, and Brugia specific IgG4.
Information By: National Institutes of Health Clinical Center (CC)
Dates:
Date Received: August 2, 2007
Date Started: July 2007
Date Completion:
Last Updated: July 30, 2015
Last Verified: July 2015
