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An Evaluation of Weekly Tafenoquine

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ClinicalTrials.gov Identifier: NCT02488980
Recruitment Status : Completed
First Posted : July 2, 2015
Results First Posted : February 24, 2017
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
SmithKline Beecham
Information provided by (Responsible Party):
U.S. Army Medical Research and Development Command

Brief 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.

Condition or disease Intervention/treatment Phase
Falciparum Parasitaemia Drug: Tafenoquine Drug: Mefloquine Drug: Placebo Phase 2

Detailed Description:
Subjects were treated for 3 days with halofantrine to clear any existing parasitaemia. At the end of the clearance period, subjects free from malaria parasitaemia were randomized and received a loading dose of the study treatment (tafenoquine 200 mg, Mefloquine 250 mg or placebo) for tree days, followed by study treatment (tafenoquine 200 mg, mefloquine 250 mg or placebo, respectively) once a week for 24 weeks. After the treatment period subjects attended weekly follow-up safety visits until week 28.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 306 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : May 2000
Actual Primary Completion Date : October 2000
Actual Study Completion Date : March 2003

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tafenoquine
Tafenoquine 200 mg for three days followed by Tafenoquine 200 once a week for 24 weeks.
Drug: Tafenoquine
Tafenoquine 200 mg for three days followed by Tafenoquine 200 mg once a week for 24 weeks.

Active Comparator: Mefloquine
Mefloquine 250 mg for three days followed by Mefloquine 250 once a week for 24 weeks.
Drug: Mefloquine
Mefloquine 250 mg for three days followed by Mefloquine 250 mg once a week for 24 weeks.

Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo for three days followed by placebo once a week for 24 weeks




Primary Outcome Measures :
  1. Prophylactic Outcome Defined by the Subject Having no Positive Smears [ Time Frame: 24 Weeks ]
    Prophylactic outcome (success/failure) at the end of the prophylactic treatment phase; outcome was based on absence/presence of asexual stage parasites of any Plasmodium species on a single blood smear.


Secondary Outcome Measures :
  1. Protective Efficacy Based on Two Consecutive Positive Smears [ Time Frame: 24 Weeks ]
    Kaplan-Meier survival curves were produced for time to parasitaemia for both first positive smear and two consecutive positive smears. Analysis was based on a calculation of protective efficacy (PE) of tefaenoquine, defined as (1-relative risk of developing parasitaemia tafenoquine: placebo) x100% and 95.5% confidence intervals were constructed for the relative risk using Koopman's method.

  2. Time to a Single Positive Smear [ Time Frame: 24 Weeks ]
    Kaplan-Meier survival curves were produced for time to parasitaemia for both first positive smear and two consecutive positive smears. 95.5% confidence intervals were constructed for the relative risk.


Other Outcome Measures:
  1. Safety (SAEs and AEs) [ Time Frame: 28 weeks ]
    The most commonly reported experiences in subject occurring in at least 20% of subjects in any treatment group.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02488980


Sponsors and Collaborators
U.S. Army Medical Research and Development Command
SmithKline Beecham
Investigators
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Principal Investigator: Jose Stoute, MD Penn State Hershey Infectious Diseases
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: U.S. Army Medical Research and Development Command
ClinicalTrials.gov Identifier: NCT02488980    
Other Study ID Numbers: A-9467
First Posted: July 2, 2015    Key Record Dates
Results First Posted: February 24, 2017
Last Update Posted: May 30, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: SmithKline Beecham
Keywords provided by U.S. Army Medical Research and Development Command:
Falciparum Parasitaemia, Malaria
Additional relevant MeSH terms:
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Parasitemia
Parasitic Diseases
Infections
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Mefloquine
Tafenoquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents