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

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
    

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.
    

Intervention name(s): DEC/Albendazole
Intervention type(s): Drug
Intervention MeSH terms: Albendazole
Primary purpose: Treatment
Keywords: Lymphatic Filariasis; Diethylcarbamazine; Microfilariae; Helminths; Nematode