Clinical Trials Logo

Clinical Trial 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 standard regimen. Lymphatic filariasis is caused by infection with very small filarial worms, particulalry Wuchereria bancroti, that are spread by mosquitoes. The infection can lead to 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 Wuchereria bancrofti may be eligible for this 28-month study. Candidates must be willing to spend 4 days in the Government General Hospital in Chennai, India, at the beginning of the study. They are screened with a medical history, a brief physical examination, ultrasound (picture generated by sound waves) of the groin or chest, and blood tests to check for infection with Wuchereria bancrofti and to measure white blood cell counts.

Participants undergo the following procedures:

-4-day hospitalization

Random assignment to receive either standard treatment (400 mg albendazole and 300 mg DEC given once a year for 2 years) or the experimental regimen (800 mg albendazole and 300 mg DEC given twice a year for 2 years)

Urine pregnancy test for women of childbearing age

Receive first treatment dose

Monitoring for symptoms

-6-month outpatient visit

Short history, physical examination and blood test

Second treatment dose for subjects receiving 800 mg albendazole

Urine pregnancy test for women of childbearing age

-1-year outpatient visit

Short history, physical examination and blood test

Second or third treatment dose, depending on treatment group

Repeat ultrasound in subjects whose first ultrasound detected adult worm

Urine pregnancy test for women of childbearing age

-18-month outpatient visit

Short history, physical examination and blood test

Fourth treatment dose for subjects receiving 800 mg albendazole

Urine pregnancy test for women of childbearing age

-24-month outpatient visit

Short history, physical examination and blood test

Final dose of albendazole and DEC at standard doses

Repeat ultrasound in subjects whose first ultrasound detected adult worms

Urine pregnancy test for women of childbearing age


Clinical Trial 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 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00375583
Study type Interventional
Source National Institutes of Health Clinical Center (CC)
Contact
Status Completed
Phase Phase 2
Start date September 9, 2006
Completion date April 28, 2011

See also
  Status Clinical Trial Phase
Completed NCT03664063 - PK PD Study of IDA and Azithromycin for NTDs ( ComboNTDs ) Phase 2
Recruiting NCT04844905 - Adjunctive Ivermectin Mass Drug Administration for Malaria Control Phase 3
Completed NCT01975441 - Eval 3-Drug Therapy Diethylcarbamize, Albendazole and Ivermectin That Could Accelerate LF Elimination Outside of Africa Phase 2
Completed NCT01629771 - Disability and Quality of Life in Patients With Lymphatic Filariasis in Rural Southern India N/A
Completed NCT01905423 - Optimization of Mass Drug Administration With Existing Drug Regimens for Lymphatic Filariasis and Onchocerciasis
Completed NCT02784743 - Impact of Albendazole -Ivermectin on Wuchereria Bancrofti in Mali Phase 4
Completed NCT03036059 - Twice Yearly Treatment for the Control of LF Phase 4
Completed NCT01905436 - Mass Drug Administration for Lymphatic Filariasis and Onchocerciasis for Liberia
Completed NCT02509481 - Repeat Ivermectin Mass Drug Administrations for Control of Malaria: a Pilot Safety and Efficacy Study Phase 2/Phase 3
Completed NCT03268252 - Optimization of MDA With Existing Drug Regimens for LF: Monitoring Efficacy of Ongoing Treatment Programs in PNG
Completed NCT02927496 - A 24 Month Study, to Compare the Efficacy of Doxycycline vs. Placebo for Improving Filarial Lymphedema in Mali Phase 3
Completed NCT02899936 - Death to Onchocerciasis and Lymphatic Filariasis (DOLF) Triple Drug Therapy for Lymphatic Filariasis N/A
Completed NCT00511004 - Effect of Albendazole Dose on Treatment of Lymphatic Filariasis Phase 2
Active, not recruiting NCT04258670 - Spontaneous Antigenemia in Loiasis
Completed NCT02974049 - Lymphatic Filariasis (LF) in Ivory Coast N/A
Terminated NCT01213576 - Efficacy of Higher Albendazole and Ivermectin Doses on Wuchereria Bancrofti Microfilarial Clearance in Malawi N/A
Completed NCT02929121 - A 24 Month Study to Compare Efficacy of Doxycycline vs Placebo for Improving Filarial Lymphedema in India Phase 3
Completed NCT00339417 - Effect of Albendazole Dose on Clearance of Filarial Worms Phase 2
Completed NCT02032043 - Optimization of Mass Drug Administration With Existing Drug Regimens for Lymphatic Filariasis and Onchocerciasis for Ivory Coast (DOLF-Ivory Coast)
Withdrawn NCT01903057 - Safety Study of Combined Azithromycin, Ivermectin and Albendazole for Trachoma and Lymphatic Filariasis Phase 4