Effect of Albendazole Dose on Clearance of Filarial Worms
Information source: National Institutes of Health Clinical Center (CC)
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphatic Filariasis; Wuchereria Bancrofti Infection
Intervention: DEC/Albendazole (Drug)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Overall contact:
V. Kumaraswami, Ph.D., Phone: Not Listed
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 Details
Official title: Effect of Albendazole Dose and Interval on Wuchereria Bancrofti Microfilarial Clearance in India: A Randomized, Open Label Study
Study design: Treatment
Primary outcome: Microfilarial levels.
Secondary outcome: Adult worm burden.
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 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
- 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.
Locations and Contacts
V. Kumaraswami, Ph.D., Phone: Not Listed
Tuberculosis Research Centre, Chennai, India
Additional Information
Related publications: Adjepon-Yamoah KK, Edwards G, Breckenridge AM, Orme ML, Ward SA. The effect of renal disease on the pharmacokinetics of diethylcarbamazine in man. Br J Clin Pharmacol. 1982 Jun;13(6):829-34. Andrade LD, Medeiros Z, Pires ML, Pimentel A, Rocha A, Figueredo-Silva J, Coutinho A, Dreyer G. Comparative efficacy of three different diethylcarbamazine regimens in lymphatic filariasis. Trans R Soc Trop Med Hyg. 1995 May-Jun;89(3):319-21. Amaral F, Dreyer G, Figueredo-Silva J, Noroes J, Cavalcanti A, Samico SC, Santos A, Coutinho A. Live adult worms detected by ultrasonography in human Bancroftian filariasis. Am J Trop Med Hyg. 1994 Jun;50(6):753-7.
Starting date: September 2006
Ending date: June 2011
Last updated: August 24, 2009
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