Effect of Albendazole Dose on Treatment of Lymphatic Filariasis

NCT00511004 | Completed Phase 2 Results

• 2 other identifiers: 99990719707-I-N197
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lymphatic Filariasis

Keywords

Brugia Malayi; Lymphatic Filariasis; Albendazole; Diethylcarbamazine

Outcome Measures

Primary Outcomes (1)

• Microfilarial Counts at 1 Year

  Night time microfilarial counts at 1 year

  1 year from time enrolled

Secondary Outcomes (3)

• Adult Worm Burdens at 2 Years

  2 years from the time enrolled.

• Microfilarial Levels at 2 Years

  2 years from time enrolled

• Brugia Specific Immunoglobulin G4 (IgG4) Antibodies

  2 years

Study Arms (3)

Diethylcarbamazine/Albendazole -STD

ACTIVE COMPARATOR

Standard therapy of DEC (300mg) and albendazole (400mg) yearly

Drug: Albendazole; Drug: Diethylcarbamazine

Diethylcarbamazine/Albendazole- HD1

ACTIVE COMPARATOR

High dose of DEC (300mg) and albendazole (800mg) yearly

Drug: Albendazole; Drug: Diethylcarbamazine

Diethylcarbamazine/Albendazole-HD2

ACTIVE COMPARATOR

High dose of DEC (300mg) and albendazole (800mg) twice yearly (every 6 months)

Drug: Albendazole; Drug: Diethylcarbamazine

Interventions

Albendazole DRUG

Comparing 400 mg to 800 mg dose

Also known as: Zentel

Diethylcarbamazine/Albendazole -STD; Diethylcarbamazine/Albendazole- HD1; Diethylcarbamazine/Albendazole-HD2

Diethylcarbamazine DRUG

Providing diethylcarbamazine more frequently in combination with albendazole

Also known as: Banocide

Diethylcarbamazine/Albendazole -STD; Diethylcarbamazine/Albendazole- HD1; Diethylcarbamazine/Albendazole-HD2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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
• Creatinine (Cr) less than or equal to 1.2 mg/dL
• Alanine aminotransferase (ALT) less than 30 U/L

You may not qualify if:

• Age less than 18 years or greater than 55 years
• Pregnant or breast feeding by history
• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Filariasis Chemotherapy Unit (FCU), T.D. Medical Hospital

Alleppey, Kerala, India

Location

Related Publications (3)

• 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: 7285488 BACKGROUND

• 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: 7020746 BACKGROUND

• 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.

  PMID: 6118029 BACKGROUND

MeSH Terms

Conditions

Elephantiasis, Filarial

Interventions

Albendazole; Diethylcarbamazine

Condition Hierarchy (Ancestors)

Filariasis; Spirurida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperazines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

Study never fully enrolled so sample size was smaller than hoped for.

Results Point of Contact

• Title: Thomas B. Nutman
• Organization: NIAID

tnutman@niaid.nih.gov

301-496-5398

Study Officials

• Thomas B Nutman, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2007
• First Posted: August 3, 2007
• Study Start: July 1, 2007
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: August 31, 2015
• Results First Posted: August 31, 2015

Record last verified: 2015-07

Locations

IN (1)