An Evaluation of Weekly Tafenoquine

NCT ID: NCT02488980

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 306 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-05-31
• Study Completion Date: 2003-03-31

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.

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.

Conditions

Falciparum Parasitaemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Tafenoquine

Tafenoquine 200 mg for three days followed by Tafenoquine 200 once a week for 24 weeks.

Group Type: EXPERIMENTAL

Tafenoquine

Intervention Type: DRUG

Tafenoquine 200 mg for three days followed by Tafenoquine 200 mg once a week for 24 weeks.

Mefloquine

Mefloquine 250 mg for three days followed by Mefloquine 250 once a week for 24 weeks.

Group Type: ACTIVE_COMPARATOR

Mefloquine

Intervention Type: DRUG

Mefloquine 250 mg for three days followed by Mefloquine 250 mg once a week for 24 weeks.

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Tafenoquine

Tafenoquine 200 mg for three days followed by Tafenoquine 200 mg once a week for 24 weeks.

Intervention Type: DRUG

Mefloquine

Mefloquine 250 mg for three days followed by Mefloquine 250 mg once a week for 24 weeks.

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

SmithKline Beecham

INDUSTRY

Sponsor Role: collaborator

U.S. Army Medical Research and Development Command

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jose Stoute, MD

Role: PRINCIPAL_INVESTIGATOR

Penn State Hershey Infectious Diseases

References

Novitt-Moreno A, Ransom J, Dow G, Smith B, Read LT, Toovey S. Tafenoquine for malaria prophylaxis in adults: An integrated safety analysis. Travel Med Infect Dis. 2017 May-Jun;17:19-27. doi: 10.1016/j.tmaid.2017.05.008. Epub 2017 May 8.

Reference Type: DERIVED

PMID: 28495354 (View on PubMed)

Other Identifiers

A-9467

Identifier Type: -

Identifier Source: org_study_id