Effect of Albendazole Dose on Clearance of Filarial Worms
Effect of Albendazole Dose and Interval on Wuchereria Bancrofti Microfilarial Clearance in India: A Randomized, Open Label Study
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
A PHASE2 clinical study on Lymphatic Filariasis and Wuchereria Bancrofti Infection, this trial is completed. The trial is conducted by National Institute of Allergy and Infectious Diseases (NIAID) and has accumulated 6 data snapshots since 2006. Infectious disease trials contribute critical data for public health response and treatment development.
Study Description(click to expand)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, 50 volunteers with microfilaremic Wuchereria bancrofti infection will be randomized to receive standard annual therapy (albendazole 400 mg + DEC 300 mg) or semiannual therapy with an increased albendazole dose (albendazole 800 mg + DEC 300 mg). 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 two years to determine whether the higher dose, more frequent regimen is more effective.
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, 50 volunteers with microfilaremic Wuchereria bancrofti infection will be randomized to receive standard annual therapy (albendazole 400 mg + DEC 300 mg) or semiannual therapy with an increased albendazole dose (albendazole 800 mg + DEC 300 mg). 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 two years to determine whether the higher dose, more frequent regimen is more effective.
Status Flow
Change History
6 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE2
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Sep 2024 — Present [monthly]
Completed PHASE2
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
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Jan 2021 — Jul 2024 [monthly]
Completed PHASE2
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE2
▶ Show 1 earlier version
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Jan 2017 — Jun 2018 [monthly]
Completed PHASE2
First recorded
Sep 2006
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- National Institute of Allergy and Infectious Diseases (NIAID)
- Tuberculosis Research Centre, India
For direct contact, visit the study record on ClinicalTrials.gov .