Effect of Albendazole Dose on Clearance of Filarial Worms
Condition: Lymphatic Filariasis
MeSH terms: Filariasis; Elephantiasis, Filarial; Elephantiasis
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      Albendazole and ivermectin are currently used in combination for annual mass treatment of
      lymphatic filariasis in 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. Furthermore, the optimal dose of ivermectin for the
      treatment of lymphatic filariasis is greater than that being used in the current mass
      treatment program. In this study, 50 volunteers with microfilaremic Wuchereria bancrofti
      infection will be randomized to receive standard annual therapy (albendazole 400 mg +
      ivermectin 150 mcg/kg) or semiannual therapy with an increased albendazole dose (albendazole
      800 mg + ivermectin 400 mcg/kg). If adequate numbers of microfilaremic subjects are
      recruited, an additional 25 volunteers will receive annual therapy with the increased dose
      combination. 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
      three years to assess the effects of the treatments.
    

Intervention name(s): Albendazole; Ivermectin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ivermectin; Albendazole
Primary purpose: Treatment
Keywords: Lymphatic Filariasis; Chemotherapy