Safety and Efficacy of IDA for Onchocerciasis
Condition: Onchocerciasis
MeSH terms: Onchocerciasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This DOLF study will investigate the safety and effectiveness of IDA treatment in persons
      with onchocerciasis when it is administered after pre-treatment with ivermectin to clear or
      greatly reduce microfilariae from the skin and eyes.
    

Detailed description: 
      This study will provide preliminary data on the safety of IDA treatment in persons with
      onchocerciasis when it is administered after pre-treatment with IVM to clear or greatly
      reduce microfilariae from the skin and eyes. Widespread use of IDA following IVM pretreatment
      (I/IDA) has the potential to greatly accelerate elimination of lymphatic filariasis (LF) in
      African countries that are co-endemic for LF and onchocerciasis. study later.

      This study will also assess the efficacy of IDA for killing and sterilizing adult filarial
      worms. An improved macrofilaricidal treatment would be a major advance for the global program
      to eliminate onchocerciasis. Since the safety and efficacy objectives are both very
      important, we have included dual primary objectives for the study.

      Primary objectives:

        -  Safety: To compare rates and types of severe adverse events (grade 3 or higher) that
           occur within 7 days following 1 day or 3 days of treatment with triple drug treatment
           ("IDA" = diethylcarbamazine (DEC) with ivermectin (IVM) and albendazole (ALB)) with the
           comparator regimen of 1 day of treatment with ivermectin and albendazole (IA) in persons
           with active Onchocerca volvulus infections after pretreatment with ivermectin alone.

        -  Efficacy: To compare the effect of three treatment regimens (1 day of IDA, 3 days of
           IDA, or IA) for killing or sterilizing adult female O. volvulus worms based on the
           percentage of all adult female worms in nodules that are alive with embryos in the
           uterus 18 months after treatment.

      This is an open label, randomized clinical trial.
    

Intervention name(s): IVM w/ ALB; Single dose of IDA; Three daily doses of IDA
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will be given a single dose of oral IVM (150 µg/kg) plus ALB (400 mg) (IVM/ALB); Participants will be given a single dose of oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg); Participants will be given one daily dose for 3 days of oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg)
Other intervention name(s): IA; IVM/DEC/ALB (x1); IVM/DEC/ALB (x3)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be split into two strata - those without ocular Mf detected six months after ivermectin pretreatment in the Part I preceding study AND without ocular Mf detected at baseline in the part II study will be in stratum 1. Those participants with ocular Mf detected 6 months after ivermectin pretreatment in the preceding study OR with ocular Mf detected at the baseline exam for this study will be in stratum 2. Stratum 1 will be enrolled first, followed by stratum 2. Members of each stratum will be evenly randomized into one of three treatment arms:
IVM + ALB - Single dose of oral IVM (150 µg/kg) plus ALB (400 mg) (IVM/ALB)
IDA x 1 dose - Single dose of oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg)
IDA x 3 doses -Once daily for 3 days oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ophthalmology