Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2026-01-22 @ 8:23 AM
Study NCT ID:
NCT00511004
Status:
COMPLETED
Last Update Posted:
2015-08-31
First Post:
2007-08-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Albendazole Dose on Treatment of Lymphatic Filariasis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D004605', 'term': 'Elephantiasis, Filarial'}], 'ancestors': [{'id': 'D005368', 'term': 'Filariasis'}, {'id': 'D017205', 'term': 'Spirurida Infections'}, {'id': 'D017190', 'term': 'Secernentea Infections'}, {'id': 'D009349', 'term': 'Nematode Infections'}, {'id': 'D006373', 'term': 'Helminthiasis'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D008209', 'term': 'Lymphedema'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015766', 'term': 'Albendazole'}, {'id': 'D004049', 'term': 'Diethylcarbamazine'}], 'ancestors': [{'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tnutman@niaid.nih.gov', 'phone': '301-496-5398', 'title': 'Thomas B. Nutman', 'organization': 'NIAID'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Study never fully enrolled so sample size was smaller than hoped for.'}}, 'adverseEventsModule': {'timeFrame': 'Every 6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Standard Therapy Annual DEC/ALB', 'description': 'Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)', 'otherNumAtRisk': 13, 'otherNumAffected': 9, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'High Dose Annual DEC/ALB', 'description': 'Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)', 'otherNumAtRisk': 13, 'otherNumAffected': 8, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'High Dose Semiannual DEC/AC=LB', 'description': 'Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)', 'otherNumAtRisk': 14, 'otherNumAffected': 11, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom'}, {'term': 'Nausea/Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Custom'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Microfilarial Counts at 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Therapy Annual DEC/ALB', 'description': 'Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)'}, {'id': 'OG001', 'title': 'High Dose Annual DEC/ALB', 'description': 'Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)'}, {'id': 'OG002', 'title': 'High Dose Semiannual DEC/ALB', 'description': 'Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '20'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '12'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '9'}]}]}], 'analyses': [{'pValue': '<0.2', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Adjusted for multiple comparisons', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '1 year from time enrolled', 'description': 'Night time microfilarial counts at 1 year', 'unitOfMeasure': 'MF/ML', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adult Worm Burdens at 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Therapy Annual DEC/ALB', 'description': 'Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)'}, {'id': 'OG001', 'title': 'High Dose Annual DEC/ALB', 'description': 'Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)'}, {'id': 'OG002', 'title': 'High Dose Semiannual DEC/ALB', 'description': 'Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'analyses': [{'pValue': '0.9', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '2 years from the time enrolled.', 'description': 'Doppler detected worm nests at 2 years', 'unitOfMeasure': 'Number of nests', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'By 2 years, 4 subjects in High Dose Group lost to followup'}, {'type': 'SECONDARY', 'title': 'Microfilarial Levels at 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Diethylcarbamazine/Albendazole -STD', 'description': 'Standard therapy of diethylcarbamazine (DEC) (300mg) and albendazole (400mg) yearly\n\nAlbendazole: Comparing 400 mg to 800 mg dose\n\nDiethylcarbamazine: Providing diethylcarbamazine more frequently in combination with albendazole'}, {'id': 'OG001', 'title': 'Diethylcarbamazine/Albendazole- HD1', 'description': 'High dose of DEC (300mg) and albendazole (800mg) yearly\n\nAlbendazole: Comparing 400 mg to 800 mg dose\n\nDiethylcarbamazine: Providing diethylcarbamazine more frequently in combination with albendazole'}, {'id': 'OG002', 'title': 'Diethylcarbamazine/Albendazole-HD2', 'description': 'High dose of DEC (300mg) and albendazole (800mg) twice yearly (every 6 months)\n\nAlbendazole: Comparing 400 mg to 800 mg dose\n\nDiethylcarbamazine: Providing diethylcarbamazine more frequently in combination with albendazole'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '2 years from time enrolled', 'description': 'Night time microfilarial levels at 2 years', 'unitOfMeasure': 'MF/ML', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'By 2 years, 4 subjects in High Dose Group lost to followup'}, {'type': 'SECONDARY', 'title': 'Brugia Specific Immunoglobulin G4 (IgG4) Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Therapy Annual DEC/ALB', 'description': 'Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)'}, {'id': 'OG001', 'title': 'High Dose Annual DEC/ALB', 'description': 'Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)'}, {'id': 'OG002', 'title': 'High Dose Semiannual DEC/ALB', 'description': 'Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)'}], 'classes': [{'categories': [{'measurements': [{'value': '150', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1000'}, {'value': '224', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2100'}, {'value': '128', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '650'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '2 years', 'description': 'IgG4 antibodies directed against Brugia malayi antigen', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'By 2 years, 4 subjects in High Dose Group lost to followup'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Therapy Annual DEC/ALB', 'description': 'Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)'}, {'id': 'FG001', 'title': 'High Dose Annual DEC/ALB', 'description': 'Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)'}, {'id': 'FG002', 'title': 'High Dose Semiannual DEC/ALB', 'description': 'Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Adults living in Kerala, India with Brugia malayi microfilaremia were recruited from field sites around the city of Alleppey and the study performed in the outpatient department of the TD Medical College.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Therapy Annual DEC/ALB', 'description': 'Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)'}, {'id': 'BG001', 'title': 'High Dose Annual DEC/ALB', 'description': 'Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)'}, {'id': 'BG002', 'title': 'High Dose Semiannual DEC/ALB', 'description': 'Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '50'}, {'value': '39', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '50'}, {'value': '37', 'groupId': 'BG002', 'lowerLimit': '19', 'upperLimit': '54'}, {'value': '37', 'groupId': 'BG003', 'lowerLimit': '18', 'upperLimit': '54'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'India', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Blood microfilaremia (mf/ml)', 'classes': [{'categories': [{'measurements': [{'value': '412', 'groupId': 'BG000', 'lowerLimit': '64', 'upperLimit': '912'}, {'value': '264', 'groupId': 'BG001', 'lowerLimit': '112', 'upperLimit': '1244'}, {'value': '384', 'groupId': 'BG002', 'lowerLimit': '108', 'upperLimit': '748'}, {'value': '384', 'groupId': 'BG003', 'lowerLimit': '64', 'upperLimit': '1244'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'MF/ML', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-30', 'studyFirstSubmitDate': '2007-08-02', 'resultsFirstSubmitDate': '2015-07-02', 'studyFirstSubmitQcDate': '2007-08-02', 'lastUpdatePostDateStruct': {'date': '2015-08-31', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-07-30', 'studyFirstPostDateStruct': {'date': '2007-08-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Microfilarial Counts at 1 Year', 'timeFrame': '1 year from time enrolled', 'description': 'Night time microfilarial counts at 1 year'}], 'secondaryOutcomes': [{'measure': 'Adult Worm Burdens at 2 Years', 'timeFrame': '2 years from the time enrolled.', 'description': 'Doppler detected worm nests at 2 years'}, {'measure': 'Microfilarial Levels at 2 Years', 'timeFrame': '2 years from time enrolled', 'description': 'Night time microfilarial levels at 2 years'}, {'measure': 'Brugia Specific Immunoglobulin G4 (IgG4) Antibodies', 'timeFrame': '2 years', 'description': 'IgG4 antibodies directed against Brugia malayi antigen'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Brugia Malayi', 'Lymphatic Filariasis', 'Albendazole', 'Diethylcarbamazine'], 'conditions': ['Lymphatic Filariasis']}, 'referencesModule': {'references': [{'pmid': '7285488', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '7020746', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '6118029', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nHealthy 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.\n\nParticipants undergo the following procedures:\n\n3-day hospital stay at the Filariasis Chemotherapy Unit of the T.D. Medical College Hospital in Kerala, India\n\n* 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.\n* Urine pregnancy test for women of childbearing age .\n* Ultrasound test to look for filarial worms.\n* Treatment dose.\n* Monitoring for symptoms\n\n 6-month 3-day hospital stay\n* Medical history, physical examination and blood test.\n* Repeat ultrasound in subjects whose first ultrasound detected adult worms.\n* Treatment dose for subjects receiving medicine every 6 months.\n* Urine pregnancy test for women of childbearing age.\n\n 1-year 3-day hospital stay\n* Medical history, physical examination and blood test.\n* Treatment dose.\n* Repeat ultrasound in subjects whose first ultrasound detected adult worms.\n* Urine pregnancy test for women of childbearing age.\n\n 18-month 3-day hospital stay\n* Medical history, physical examination and blood test.\n* Treatment dose for subjects receiving medicine every 6 months.\n* Urine pregnancy test for women of childbearing age.\n\n 24-month 3-day hospital stay\n* Medical history, physical examination and blood test.\n* Treatment dose.\n* Repeat ultrasound in subjects whose first ultrasound detected adult worms.\n* Urine pregnancy test for women of childbearing age.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n\nInclusion Criteria for Screening:\n\n* Age 18 years to 55 years inclusive\n* Both genders\n* Not pregnant or breastfeeding by history\n* 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\n* If selected, subjects must be willing to undergo nighttime blood draws once every 6 months and Doppler ultrasound twice yearly for 2 years\n* If selected, agree to have blood stored for future studies\n* Ability to understand and give informed consent\n\nInclusion Criteria for Treatment:\n\n* Age 18 to 55 years inclusive\n* Men and non-pregnant or non-breast feeding women\n* Microfilarial levels greater than 50mf/mL\n* 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\n* Willingness to undergo nighttime blood draws once every 6 months for 2 years\n* Ability to understand and give informed consent\n* Hemaglobin (Hgb) levels for inclusion greater than 9 g/dL\n* Creatinine (Cr) less than or equal to 1.2 mg/dL\n* Alanine aminotransferase (ALT) less than 30 U/L\n* Willingness to have blood stored for future studies\n\nEXCLUSION CRITERIA:\n\nExclusion Criteria for Screening:\n\n* Age less than 18 years or greater than 55 years\n* Pregnant or breast feeding by history\n\nExclusion Criteria for Treatment:\n\n* Non-volunteers\n* Age less than 18 years or greater than 55 years\n* Pregnant or breast feeding\n* Hgb levels less than or equal to 9 g/dL\n* Cr greater than 1.3 mg/dL\n* ALT greater than 30 U/L\n* Alcohol consumption of more than 2 beers or other alcohol-containing drinks/day within a week of each drug administration\n* Temperature greater than 37.5 degrees Celsius\n* Serious medical illness\n* History of benzimidazole allergy\n* History of DEC allergy\n* Use of albendazole or DEC within past 6 months\n* Unwillingness to comply with required study visits'}, 'identificationModule': {'nctId': 'NCT00511004', 'briefTitle': 'Effect of Albendazole Dose on Treatment of Lymphatic Filariasis', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Effect of Albendazole Dose and Interval on Brugia Malayi Microfilarial Clearance in India: A Randomized, Open Label Study', 'orgStudyIdInfo': {'id': '999907197'}, 'secondaryIdInfos': [{'id': '07-I-N197', 'type': 'OTHER', 'domain': 'NIAID IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Diethylcarbamazine/Albendazole -STD', 'description': 'Standard therapy of DEC (300mg) and albendazole (400mg) yearly', 'interventionNames': ['Drug: Albendazole', 'Drug: Diethylcarbamazine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Diethylcarbamazine/Albendazole- HD1', 'description': 'High dose of DEC (300mg) and albendazole (800mg) yearly', 'interventionNames': ['Drug: Albendazole', 'Drug: Diethylcarbamazine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Diethylcarbamazine/Albendazole-HD2', 'description': 'High dose of DEC (300mg) and albendazole (800mg) twice yearly (every 6 months)', 'interventionNames': ['Drug: Albendazole', 'Drug: Diethylcarbamazine']}], 'interventions': [{'name': 'Albendazole', 'type': 'DRUG', 'otherNames': ['Zentel'], 'description': 'Comparing 400 mg to 800 mg dose', 'armGroupLabels': ['Diethylcarbamazine/Albendazole -STD', 'Diethylcarbamazine/Albendazole- HD1', 'Diethylcarbamazine/Albendazole-HD2']}, {'name': 'Diethylcarbamazine', 'type': 'DRUG', 'otherNames': ['Banocide'], 'description': 'Providing diethylcarbamazine more frequently in combination with albendazole', 'armGroupLabels': ['Diethylcarbamazine/Albendazole -STD', 'Diethylcarbamazine/Albendazole- HD1', 'Diethylcarbamazine/Albendazole-HD2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alleppey, Kerala', 'country': 'India', 'facility': 'Filariasis Chemotherapy Unit (FCU), T.D. Medical Hospital', 'geoPoint': {'lat': 9.49004, 'lon': 76.3264}}], 'overallOfficials': [{'name': 'Thomas B Nutman, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of Allergy and Infectious Diseases (NIAID)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}