Overview

Phase 2 Open Label Study of Tafenoquine for Treatment of Chronic Babesiosis Patients with Severe Fatigue

Eligibility

Inclusion Criteria:

• Male or female, aged ≥ 18 years
• Severe disabling fatigue
• Have at least one common symptom of babesiosis
• Have laboratory evidence of exposure to babesia in the last 12 months
• Able and willing to give written informed consent
• Able and willing to perform all study assessments
• If female negative urine pregnancy test and
• If female agree to use an acceptable method of birth control

Exclusion Criteria:

• Glucose-6-phosphate-dehydrogenase (G6PD) deficiency
• Breastfeeding
• Unmanaged Psychotic disorder
• Known hypersensitivity reaction to tafenoquine or other 8-aminoquinolines
• Current or planned treatment with quinine
• Uncontrolled cardiopulmonary or endocrine disorders
• Taking OCT2/MATE substrates without appropriate medical oversight
• Medical history of chronic, active viral diseases including HIV/AIDS, hepatitis B, and hepatitis C
• Have a risk factors for relapsing babesiosis
• Anorexia
• Any concomitant significant illness unrelated to babesiosis
• The patient is unable to tolerate medication by the oral route
• The patient has previously taken tafenoquine
• Hemoglobin at baseline is ≤ 8 g/dL