Fexinidazole in Human African Trypanosomiasis Due to T.b. Gambiense at Any Stage

Inclusion Criteria

• •Male or female patient, including breastfeeding or pregnant women in the second or third trimester.
• •≥ 6 years of age.
• •≥ 20 kg body weight.
• •Signed Informed Consent Form and Assent Form for patients less than 18 years of age
• •Trypanosomes detected in any body fluid.
• •Physically able to ingest at least one solid meal per day.
• •Able to take oral medication.
• •Karnofsky Performance Status \> 40%.
• •Able to comply with the schedule of follow-up visits and with the study constraints.
• •Easily reachable during the out-patient follow-up period.
• •Willing to undergo lumbar punctures.
• •Recovery period after antimalarial treatment and/or treatment of helminthiasis (at least 3 days).
• •Uncontrolled diabetes or hypertension or any patients requiring clinical stabilization; wait until appropriate treatment to control the disease has been initiated.
• •First trimester of pregnancy.
• •Traumatic lumbar puncture at Screening i.e. red blood cells visible in cerebrospinal fluid (CSF); wait for 48 hours before repeating lumbar puncture.
• •Eligibility Criteria for Out-patient Treatment
• •Accepting to be treated on an out-patient basis;
• •Karnofsky Performance Status \> 50%;
• •Good understanding of the method of administration of fexinidazole by the patient and/or caregiver\* (checked using a questionnaire at the time of dispensing fexinidazole);
• •Residing close to the investigational center, i.e. approximately one hour by road and/or boat, during the treatment period\*\*;
• •Easily reachable during the treatment period;
• •No medical or psychiatric contraindications for treatment as out-patient;
• •No pregnancy or breastfeeding;
• •No neurological symptoms.