Effect of Albendazole Dose on Clearance of Filarial Worms

NCT00339417 | Completed Phase 2

• 2 other identifiers: 99990610706-I-N107
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study, conducted in Mali, West Africa, will determine whether a new treatment regimen for lymphatic filariasis can eliminate the disease more quickly than the standard regimen. Lymphatic filariasis is caused by infection with very small filarial worms called Wuchereria bancrofti that are spread by mosquitoes. The disease can cause swelling of the arms, legs, breast and genitalia and can progress to permanent swelling of the legs or arms called elephantiasis. Currently, patients in Mali are treated with a single dose of 400 mg of albendazole plus two doses of 200 mcg/kg of ivermectin each year. This study will use a regimen of 800 mg of albendazole twice a year plus 200 mcg/kg of ivermectin twice a year for 2 years. The study will see if the new regimen is more effective in lowering the numbers of Wuchereria bancrofti in the blood and will examine the effects of the two treatments on the adult worms living in the lymph system. Healthy people between 14 and 65 years of age who live in the Mali village of N'Tessoni and are infected with Wuchereria bancrofti may be eligible for this study. Candidates are screened with a medical history, a brief physical examination and blood tests to check for infection with Wuchereria bancrofti and to measure white blood cell counts. Participants undergo the following procedures:

• First visit Ultrasound examination to look for filarial worms in the body. Random assignment to receive either standard treatment or the experimental regimen Urine pregnancy test for women of child-bearing age. Receive first treatment dose.
• 6-month visit Short history, physical examination and blood test. Second treatment dose for subjects in experimental treatment group. Urine pregnancy test for women of childbearing age.
• 1-year 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 worms. Urine pregnancy test for women of childbearing age.
• 18-month visit Short history, physical examination and blood test. Fourth treatment dose for subjects in experimental treatment group. Urine pregnancy test for women of childbearing age.
• 24-month visit Short history, physical examination and blood test. Repeat ultrasound in subjects whose first ultrasound detected adult worms. Urine pregnancy test for women of childbearing age.

Conditions

Lymphatic Filariasis

Keywords

Lymphatic Filariasis; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Wb microfilarial levels

  12 months

Secondary Outcomes (1)

• Adult worm burden as assessed by circulating antigen levels and visualization of worm nests by ultrasound

  12 months

Interventions

Albendazole DRUG

Ivermectin DRUG

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• age 14 to 65.
• men and women\*.
• Please note: women are not permitted to leave their homes at night without the approval of their husband or, if they are not married, a parent or male guardian. Since this protocol involves blood drawing at night, such approval is necessary for participation.

You may not qualify if:

• non-volunteers.
• age less than 14 or greater than 65.
• pregnant by history.
• age 14 to 65 years.
• men and women.\*
• Wb microfilarial count greater than or equal to 50 mf/ml.
• non-volunteers.
• age less than 14 or greater than 65.
• pregnancy.
• Hgb less than 9 g/dl.
• Heavy alcohol use (more than 7 beer or other alcohol-containing drink/week).
• Temperature greater than 37.5C or other serious medical illnesses.
• history of benzimidazole allergy.
• history of ivermectin allergy.
• use of albendazole or ivermectin within the past 6 months.

Sponsors & Collaborators

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

Study Sites (1)

University of Bamako, Faculty of Medicine, Pharmacy and Odontostomatology

Bamako, Mali

Location

Related Publications (3)

• Beach MJ, Streit TG, Addiss DG, Prospere R, Roberts JM, Lammie PJ. Assessment of combined ivermectin and albendazole for treatment of intestinal helminth and Wuchereria bancrofti infections in Haitian schoolchildren. Am J Trop Med Hyg. 1999 Mar;60(3):479-86. doi: 10.4269/ajtmh.1999.60.479.

  PMID: 10466981 BACKGROUND

• Addiss DG, Beach MJ, Streit TG, Lutwick S, LeConte FH, Lafontant JG, Hightower AW, Lammie PJ. Randomised placebo-controlled comparison of ivermectin and albendazole alone and in combination for Wuchereria bancrofti microfilaraemia in Haitian children. Lancet. 1997 Aug 16;350(9076):480-4. doi: 10.1016/S0140-6736(97)02231-9.

  PMID: 9274584 BACKGROUND

• Horton J, Witt C, Ottesen EA, Lazdins JK, Addiss DG, Awadzi K, Beach MJ, Belizario VY, Dunyo SK, Espinel M, Gyapong JO, Hossain M, Ismail MM, Jayakody RL, Lammie PJ, Makunde W, Richard-Lenoble D, Selve B, Shenoy RK, Simonsen PE, Wamae CN, Weerasooriya MV. An analysis of the safety of the single dose, two drug regimens used in programmes to eliminate lymphatic filariasis. Parasitology. 2000;121 Suppl:S147-60. doi: 10.1017/s0031182000007423.

  PMID: 11386686 BACKGROUND

MeSH Terms

Conditions

Elephantiasis, Filarial

Interventions

Albendazole; Ivermectin

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; Macrolides; Polyketides; Lactones

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: February 22, 2006
• Primary Completion: August 1, 2008
• Study Completion: August 17, 2011
• Last Updated: July 2, 2017

Record last verified: 2011-08-17

Locations

MA (1)