An Evaluation of Weekly Tafenoquine
Information source: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Falciparum Parasitaemia
Intervention: Tafenoquine (Drug); Mefloquine (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: U.S. Army Medical Research and Materiel Command Official(s) and/or principal investigator(s):
Jose Stoute, MD, Principal Investigator, Affiliation: Penn State Hershey Infectious Diseases
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.
Clinical Details
Official title: A Randomized, Double Blind, Placebo Controlled Evaluation of Weekly Tafenoquine (WR 238605/SB252263) Compared to Mefloquine for Chemosuppression of Plasmodium Falciparum in Western Kenya
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Prophylactic outcome defined by the subject having no positive smears.
Secondary outcome: Number of subjects with two consecutive positive smears.Number of subjects with a single positive smear during the prophylactic treatment phase plus follow-up. Number of subjects with two consecutive positive smears Time to a single positive smear. Time to two consecutive positive smears
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: May 2000
Last updated: July 1, 2015
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