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

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.
    

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, 75 volunteers with microfilaremic Brugia malayi infection will be randomized to
      receive standard annual therapy (albendazole 400 mg + DEC 300 mg), annual therapy with
      increased dosing of albendazole (albendazole 800 mg + DEC 300 mg), or semiannual therapy with
      an increased albendazole dose (albendazole 800 mg + DEC 300 mg). Microfilarial levels will be
      followed every 6 months for 2 years to determine whether the higher dose, and/or the more
      frequent regimen, is more effective.
    

Intervention name(s): Albendazole; Diethylcarbamazine
Intervention type(s): Drug; Drug
Intervention description(s): Comparing 400 mg to 800 mg dose; Providing diethylcarbamazine more frequently in combination with albendazole
Other intervention name(s): Zentel; Banocide
Intervention MeSH terms: Albendazole; Diethylcarbamazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Brugia Malayi; Lymphatic Filariasis; Albendazole; Diethylcarbamazine