Effect of Albendazole Dose on Treatment of Lymphatic Filariasis
Condition: Lymphatic Filariasis
MeSH terms: Filariasis; Elephantiasis, Filarial; Elephantiasis
Intervention: Albendazole; Diethylcarbamazine
Intervention description: Comparing 400 mg to 800 mg dose; Providing diethylcarbamazine more frequently in combination with albendazole
Intervention MeSH terms: Albendazole; Diethylcarbamazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Brugia Malayi; Lymphatic Filariasis; Albendazole; Diethylcarbamazine

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.
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

        Inclusion Criteria for Screening:

          -  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

        Inclusion Criteria for Treatment:

          -  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

          -  Hemaglobin (Hgb) levels for inclusion greater than 9 g/dL

          -  Creatinine (Cr) less than or equal to 1.2 mg/dL

          -  Alanine aminotransferase (ALT) less than 30 U/L

          -  Willingness to have blood stored for future studies

        EXCLUSION CRITERIA:

        Exclusion Criteria for Screening:

          -  Age less than 18 years or greater than 55 years

          -  Pregnant or breast feeding by history

        Exclusion Criteria for Treatment:

          -  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