- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00511004
Effect of Albendazole Dose on Treatment of Lymphatic Filariasis
Effect of Albendazole Dose and Interval on Brugia Malayi Microfilarial Clearance in India: A Randomized, Open Label Study
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.
- Repeat ultrasound in subjects whose first ultrasound detected adult worms.
- Treatment dose for subjects receiving medicine every 6 months.
Urine pregnancy test for women of childbearing age.
1-year 3-day hospital stay
- Medical history, physical examination and blood test.
- Treatment dose.
- Repeat ultrasound in subjects whose first ultrasound detected adult worms.
Urine pregnancy test for women of childbearing age.
18-month 3-day hospital stay
- Medical history, physical examination and blood test.
- Treatment dose for subjects receiving medicine every 6 months.
Urine pregnancy test for women of childbearing age.
24-month 3-day hospital stay
- Medical history, physical examination and blood test.
- Treatment dose.
- Repeat ultrasound in subjects whose first ultrasound detected adult worms.
- Urine pregnancy test for women of childbearing age.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Alleppey, Kerala, India
- Filariasis Chemotherapy Unit (FCU), T.D. Medical Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Diethylcarbamazine/Albendazole -STD
Standard therapy of DEC (300mg) and albendazole (400mg) yearly
|
Comparing 400 mg to 800 mg dose
Other Names:
Providing diethylcarbamazine more frequently in combination with albendazole
Other Names:
|
Active Comparator: Diethylcarbamazine/Albendazole- HD1
High dose of DEC (300mg) and albendazole (800mg) yearly
|
Comparing 400 mg to 800 mg dose
Other Names:
Providing diethylcarbamazine more frequently in combination with albendazole
Other Names:
|
Active Comparator: Diethylcarbamazine/Albendazole-HD2
High dose of DEC (300mg) and albendazole (800mg) twice yearly (every 6 months)
|
Comparing 400 mg to 800 mg dose
Other Names:
Providing diethylcarbamazine more frequently in combination with albendazole
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Microfilarial Counts at 1 Year
Time Frame: 1 year from time enrolled
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Night time microfilarial counts at 1 year
|
1 year from time enrolled
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adult Worm Burdens at 2 Years
Time Frame: 2 years from the time enrolled.
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Doppler detected worm nests at 2 years
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2 years from the time enrolled.
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Microfilarial Levels at 2 Years
Time Frame: 2 years from time enrolled
|
Night time microfilarial levels at 2 years
|
2 years from time enrolled
|
Brugia Specific Immunoglobulin G4 (IgG4) Antibodies
Time Frame: 2 years
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IgG4 antibodies directed against Brugia malayi antigen
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2 years
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Edwards G, Awadzi K, Breckenridge AM, Gilles HM, Orme ML, Ward SA. Diethylcarbamazine disposition in patients with onchocerciasis. Clin Pharmacol Ther. 1981 Oct;30(4):551-7. doi: 10.1038/clpt.1981.202.
- Taylor HR, Greene BM. Ocular changes with oral and transepidermal diethylcarbamazine therapy of onchocerciasis. Br J Ophthalmol. 1981 Jul;65(7):494-502. doi: 10.1136/bjo.65.7.494.
- Partono F, Purnomo, Oemijati S, Soewarta A. The long term effects of repeated diethylcarbamazine administration with special reference to microfilaraemia and elephantiasis. Acta Trop. 1981 Sep;38(3):217-25.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Lymphatic Diseases
- Vector Borne Diseases
- Parasitic Diseases
- Spirurida Infections
- Secernentea Infections
- Nematode Infections
- Helminthiasis
- Lymphedema
- Filariasis
- Elephantiasis, Filarial
- Elephantiasis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antiprotozoal Agents
- Antiparasitic Agents
- Filaricides
- Antinematodal Agents
- Anthelmintics
- Antiplatyhelmintic Agents
- Lipoxygenase Inhibitors
- Anticestodal Agents
- Albendazole
- Diethylcarbamazine
Other Study ID Numbers
- 999907197
- 07-I-N197 (Other Identifier: NIAID IRB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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