Randomized Clinical Trial, Double-blind, Single-dose Drug and Escalating Infection Intensities, Evaluating the Safety and Efficacy of Moxidectin 2 mg, Ivermectin-controlled, in Loa Loa Microfilaremic Patients
This study aims at evaluating the safety and efficacy of Moxidectin 2 mg in patients with low intensities of microfilariae of Loa loa.
• Informed consent written, signed (or with a cross) and dated
• Men aged 18 to 65 included (women not included in the study)
• Microfilarial density between 1 and 1,000 mf/mL
• body weight ≥ 45 kg and less than 85 kg
• Good general condition, as determined by the medical questionnaire and clinical examination
• Hematological parameters and adequate renal and hepatic functions, such as:
‣ Leukocytes ≥ 2,800 and ≤ 11,300 cells/mL
⁃ Hemoglobin ≥ 10.0 g/dL
⁃ Platelets ≥100,000/mm3
⁃ Serum creatinine ≤ 2.5 upper limit (UL) of the laboratory
⁃ Total bilirubinemia ≤ 2.5 x UL
⁃ ALAT ≤ 2.5 x UL
⁃ Negative urinary strip: absence of leucocyturia, hematuria, and proteinuria (in case of positivity, a second urinary strip test will be made, for confirmation)