Effect of Albendazole Dose on Treatment of Lymphatic Filariasis

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.

• INCLUSION CRITERIA:

Inclusion criteria

for Screening:

• Age 18 years to 55 years inclusive
• Both genders
• Not pregnant or breastfeeding by history
• If selected, subjects must be willing to spend 3 days on the Filariasis Chemotherapy Unit at the T.D. Medical College Hospital, Alleppey, Kerala, India
• If selected, subjects must be willing to undergo nighttime blood draws once every 6 months and Doppler ultrasound twice yearly for 2 years
• If selected, agree to have blood stored for future studies
• Ability to understand and give informed consent

Inclusion criteria

for Treatment:

• Age 18 to 55 years inclusive
• Men and non-pregnant or non-breast feeding women
• Microfilarial levels greater than 50mf/mL
• Willingness to spend 3 days on the Filariasis Chemotherapy Unit at the T.D. Medical College Hospital, Alleppey, Kerala, India every 6 months for 2 years
• Willingness to undergo nighttime blood draws once every 6 months for 2 years
• Ability to understand and give informed consent
• Hemaglobin (Hgb) levels for inclusion greater than 9 g/dL
• Creatinine (Cr) less than or equal to 1.2 mg/dL
• Alanine aminotransferase (ALT) less than 30 U/L
• Willingness to have blood stored for future studies

Exclusion criteria

Exclusion criteria

for Screening:

• Age less than 18 years or greater than 55 years
• Pregnant or breast feeding by history

Exclusion criteria

for Treatment:

• Non-volunteers
• Age less than 18 years or greater than 55 years
• Pregnant or breast feeding
• Hgb levels less than or equal to 9 g/dL
• Cr greater than 1.3 mg/dL
• ALT greater than 30 U/L
• Alcohol consumption of more than 2 beers or other alcohol-containing drinks/day within a week of each drug administration
• Temperature greater than 37.5 degrees Celsius
• Serious medical illness
• History of benzimidazole allergy
• History of DEC allergy
• Use of albendazole or DEC within past 6 months
• Unwillingness to comply with required study visits