An Evaluation of Weekly Tafenoquine
Condition: Falciparum Parasitaemia
MeSH terms: Parasitemia
Intervention: Tafenoquine; Mefloquine; Placebo
Intervention description: Tafenoquine 200 mg for three days followed by Tafenoquine 200 mg once a week for 24 weeks.; Mefloquine 250 mg for three days followed by Mefloquine 250 mg once a week for 24 weeks.; Placebo for three days followed by placebo once a week for 24 weeks
Intervention MeSH terms: Mefloquine; Tafenoquine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 306.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Falciparum Parasitaemia, Malaria

Summary:

      This was a placebo controlled, randomised, double-blind, double-dummy study of the efficacy
      of weekly tafenoquine compared with weekly mefloquine or placebo in the chemosuppression of
      P. falciparum in Nyanza Province, western Kenya.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male or female volunteers who provided informed consent (a healthy volunteer
             was defined as one who was free of ailments that might cause difficulty in evaluating
             drug efficacy or adverse experiences).

          -  Subjects aged 18-55 years.

          -  Subjects planning to reside in the study area for the entire study duration of
             approximately 70 weeks

        Exclusion Criteria:

          -  Subjects with positive parasitaemia following halofantrine treatment for radical cure.

          -  Subjects with any medical condition which, in the opinion of the investigator, made
             the subject unsuitable to enter the study.

          -  Subjects with personal or family history of seizures.

          -  Female subjects with a positive serum beta-HCG5 (tested during screening and within 48
             hours of first drug administration and approximately monthly thereafter).

          -  Women who were pregnant or lactating or who in the opinion of the investigator were at
             risk of becoming pregnant.

          -  Subjects with clinically significant abnormalities (to include but not limited to
             abnormal hepatic or renal function) as determined by history, physical and routine
             blood chemistries and haematology values. Subjects who had demonstrated
             hypersensitivity to any of the study drugs especially to any other 8-aminoquinolines.

          -  Subjects unwilling to report for drug administration or blood drawing during the 70
             week duration of the study.

          -  Subjects with G6PD deficiency.

          -  Subjects with laboratory guideline values for exclusion: haemoglobin <10 gm/dL,
             platelets <80,000/mm3, WBC <3000ul3, creatinine or ALT more than twice the upper limit
             of normal for age.

          -  Subjects with an abnormal ECG, particularly an extended QTc interval > 0.42 seconds.

          -  Subjects taking any other anti-malarial product, or who had taken an antimalarial drug
             other than halofantrine within the previous two weeks.

          -  Subjects who had received an investigational drug (a new chemical entity not
             registered for use) within 30 days or 5 half-lives whichever was the longer.

          -  Subjects with a history of psychiatric disorder.