Status:
COMPLETED
Effect of Albendazole Dose on Clearance of Filarial Worms
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Tuberculosis Research Centre, India
Conditions:
Lymphatic Filariasis
Wuchereria Bancrofti Infection
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
This study, conducted in Chennai, India, will determine whether a new treatment regimen of albendazole and diethylcarbamazine for lymphatic filariasis can eliminate the disease more quickly than the s...
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 donat...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA (SCREENING):
- Age 18 years to 55 years inclusive.
- Both genders.
- Not pregnant or breastfeeding by history.
- If selected, subject must be willing to spend 3 days on the Clinical Trials Unit of the Government General Hospital, Chennai India.
- If selected, subject must be willing to undergo nighttime blood draws every 6 months for 2 years.
- If selected, agree to have blood stored for future studies.
- Ability to understand and sign the informed consent.
- EXCLUSION CRITERIA (SCREENING):
- Non-volunteers.
- Age less than 18 years or greater than 55 years.
- Pregnant or breastfeeding by history.
- INCLUSION (TREATMENT):
- Age 18 years to 55 years.
- Men and non-pregnant or non-breastfeeding women.
- Microfilarial levels greater than 50 mf/ml.
- Willingness to spend 3 days on the Clinical Trials Unit of the Government General Hospital, Chennai India.
- Willingness to undergo nighttime blood draws every 6 months for 2 years.
- Ability to understand and sign the informed consent.
- Hb levels for inclusion greater than 9 g/dL.
- Normal Cr, ALT.
- Willingness to have blood stored for future studies.
- EXCLUSION (TREATMENT):
- Non-volunteers.
- Age less than 18 years or greater than 55 years.
- Pregnancy or breast-feeding.
- Hgb less than or equal to 9 g/dL.
- Cr greater than 1.2/100 ml.
- ALT greater than 30 U.
- Alcohol consumption of more than 2 beers or other alcohol-containing drink/day within a week of each drug administration.
- Temperature greater than 37.5 degrees C.
- 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.
Exclusion
Key Trial Info
Start Date :
September 9 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 28 2011
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT00375583
Start Date
September 9 2006
End Date
April 28 2011
Last Update
July 2 2017
Active Locations (1)
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1
Tuberculosis Research Centre
Chennai, India