Pharmacokinetics & Pharmacodynamics of Diethylcarbamazine (DEC)+ Albendazole (ALB) + Ivermectin (IVE)
Condition: Wuchereria Bancrofti Infection
MeSH terms: Infections; Filariasis; Elephantiasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will be an open label cohort study with 2 two-treatment groups 2). Both groups will
      be treated with a single oral administration of Diethylcarbamazine (DEC) 6 mg/kg +
      Albendazole (ALB) 400 mg + Ivermectin (IVR) 200 µg/kg (IDA). One treatment group will include
      men and women with W. bancrofti infections (>50 Mf/ml, N=30). The other treatment group will
      include men and women who are free of W. bancrofti infection based on negative blood tests
      for both microfilariae (Mf) and circulating filarial antigen (N=30). Active follow-up for
      adverse events (AE) will be for 72hrs and passive follow-up for 7 days following treatment.

      Participants will be followed again at 1 year to evaluate treatment efficacy. Individuals
      with severe AEs (grade 3 or higher) will be transported to the Agboville District Hospital
      and cared for by the hospital staff. Based on treatment of over 100 Lymphatic filariasis (LF)
      infected individuals any AEs develop within the first 72 hours following treatment and
      uncommonly up to 7 days post-treatment.

      All individuals will be admitted to a single health center or hospital in Côte d'Ivoire.

      Subjects will be monitored for 72-hours after treatment for safety and to facilitate sampling
      for drug analyses and safety tests. Participants will undergo clinical monitoring every 6
      hours to evaluate potential adverse effects of Ivermectin + Diethylcarbamazine + Albendazole
      (IDA) treatment. Participants will also be monitored for hematologic, or biochemical
      abnormalities during the period of observation.
    

Detailed description: 
      The study will be an open label cohort study with 2 two-treatment groups. Both groups will be
      treated with a single oral administration of DEC 6 mg/kg + ALB 400 mg + IVR 200 µg/kg (IDA).
      One treatment group will include men and women with W. bancrofti infections (>50 Mf/ml,
      N=30). The other treatment group will include men and women who are free of W. bancrofti
      infection based on negative blood tests for both microfilariae and circulating filarial
      antigen (N=30). Active follow-up for adverse events (AE) will be for 72 hours and passive
      follow-up for 7 days following treatment.

      Participants will be followed again at 1 year to evaluate treatment efficacy. Individuals
      with severe AEs (grade 3 or higher) will be transported to the Agboville District Hospital
      and cared for by the hospital staff. Based on treatment of over 100 LF infected individuals
      any AEs develop within the first 72 hours following treatment and uncommonly up to 7 days
      post-treatment.

      All individuals will be admitted to a single health center or hospital in Côte d'Ivoire.

      Subjects will be monitored for 72-hours after treatment for safety and to facilitate sampling
      for drug analyses and safety tests. Participants will undergo clinical monitoring every 6
      hours to evaluate potential adverse effects of IDA treatment. Participants will also be
      monitored for hematologic, or biochemical abnormalities during the period of observation.

      At enrollment all subjects will be otherwise healthy adult men and women (≥18-65 years of
      age). All individuals will be assessed for the presence and burden of geohelminth infections,
      parasitic worms of the gastrointestinal tract such as hookworm, Trichuris trichiuria and
      Ascaris lumbricoides. This is important because two of the drugs in the combination (ALB and
      IVM) are active against geohelminths. Individuals with heavy geohelminth burdens may
      experience adverse reactions because of rapid killing of their intestinal parasites.
    

Intervention name(s): Ivermectin, Diethylcarbamazine Albendazole (IDA)
Intervention type(s): Drug
Intervention description(s): To evaluate the safety and tolerability of triple drug therapy (a single dose of ALB, IVM and DEC)
Other intervention name(s): IDA
Intervention MeSH terms: Ivermectin; Albendazole; Diethylcarbamazine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other