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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00511004 |
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
Monitoring for symptoms
6-month 3-day hospital stay
Urine pregnancy test for women of childbearing age.
1-year 3-day hospital stay
Urine pregnancy test for women of childbearing age.
18-month 3-day hospital stay
Urine pregnancy test for women of childbearing age.
24-month 3-day hospital stay
Condition | Intervention | Phase |
---|---|---|
Lymphatic Filariasis Brugia Malayi Infection |
Drug: Albendazole Drug: Diethylcarbamazine |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study |
Official Title: | Effect of Albendazole Dose and Interval on Brugia Malayi Microfilarial Clearance in India: A Randomized, Open Label Study |
Estimated Enrollment: | 10000 |
Study Start Date: | July 2007 |
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.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria for Screening:
Inclusion Criteria for Treatment:
EXCLUSION CRITERIA:
Exclusion Criteria for Screening:
Exclusion Criteria for Treatment:
Contact: Thomas B. Nutman, M.D. | (301) 496-5398 | tnutman@niaid.nih.gov |
India | |
Filariasis Chemotherapy Unit (FCU), T.D. Medical Hospital | Recruiting |
Alleppey, Kerala, India |
Responsible Party: | National Institutes of Health ( Thomas B. Nutman, M.D./National Institute of Allergy and Infectious Diseases ) |
Study ID Numbers: | 999907197, 07-I-N197 |
Study First Received: | August 2, 2007 |
Last Updated: | October 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00511004 |
Health Authority: | United States: Federal Government |
Brugia Malayi Lymphatic Filariasis Albendazole Diethylcarbamazine Lymphatic Filariasis |
Albendazole Lymphedema Lymphatic Diseases Diethylcarbamazine Lymphatic filariasis |
Elephantiasis, Filarial Filariasis Parasitic Diseases Nematode Infections Helminthiasis |
Anti-Infective Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Filaricides Antineoplastic Agents Antiplatyhelmintic Agents Mitosis Modulators Enzyme Inhibitors Anthelmintics Antimitotic Agents Infection |
Lipoxygenase Inhibitors Pharmacologic Actions Anticestodal Agents Spirurida Infections Antiparasitic Agents Therapeutic Uses Tubulin Modulators Elephantiasis Antinematodal Agents Secernentea Infections |