A Randomized, Double-blind, Placebo-controlled Evaluation of Increasing Doses of Weekly Tafenoquine for Chemosuppression of Plasmodium Falciparum

NCT ID: NCT02488902

Last Updated: 2018-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 521 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-08-31
• Study Completion Date: 2003-03-31

Brief Summary

This was a randomised, double-blind, placebo-controlled study to compare the efficacy of a range four weekly doses of tafenoquine, and weekly mefloquine, with placebo as chemosuppression of P. falciparum malaria. Medications and placebo were matched and a double-dummy technique enabled blinding of tafenoquine versus mefloquine.

Conditions

Malaria

Study Design

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

Study Groups

Placebo

Placebo was administered initially as a loading course of one capsule daily for 3 days, followed by a weekly dosing regimen at the same dose.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Tafenoquine 25mg

Tafenoquine was administered initially as a loading course of one capsule daily for 3 days, followed by a weekly dosing regimen at the same dose.

Group Type: EXPERIMENTAL

Tafenoquine 25mg

Intervention Type: DRUG

Tafenoquine 25mg

Tafenoquine 50mg

Tafenoquine was administered initially as a loading course of one capsule daily for 3 days, followed by a weekly dosing regimen at the same dose.

Group Type: EXPERIMENTAL

Tafenoquine 50mg

Intervention Type: DRUG

Tafenoquine 50mg

Tafenoquine 100 mg

Tafenoquine was administered initially as a loading course of one capsule daily for 3 days, followed by a weekly dosing regimen at the same dose.

Group Type: EXPERIMENTAL

Tafenoquine 100 mg

Intervention Type: DRUG

Tafenoquine 100 mg

Tafenoquine 200 mg

Tafenoquine was administered initially as a loading course of one capsule daily for 3 days, followed by a weekly dosing regimen at the same dose.

Group Type: EXPERIMENTAL

Tafenoquine 200 mg

Intervention Type: DRUG

Tafenoquine 200 mg

Mefloquine 250 mg

Mefloquine was administered initially as a loading course of one capsule daily for 3 days, followed by a weekly dosing regimen at the same dose.

Group Type: EXPERIMENTAL

Mefloquine 250 mg

Intervention Type: DRUG

Mefloquine 250 mg

Interventions

Placebo

Placebo

Intervention Type: DRUG

Tafenoquine 25mg

Tafenoquine 25mg

Intervention Type: DRUG

Tafenoquine 50mg

Tafenoquine 50mg

Intervention Type: DRUG

Tafenoquine 100 mg

Tafenoquine 100 mg

Intervention Type: DRUG

Tafenoquine 200 mg

Tafenoquine 200 mg

Intervention Type: DRUG

Mefloquine 250 mg

Mefloquine 250 mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Willing subjects in good general health.

• Males aged 18 to 60; females aged 50 to 60.
• Subjects who planned to stay in the study area until the end of the study.

Exclusion Criteria

• Subjects with any cardiovascular, liver, neurologic, or renal function abnormality which, in the opinion of the clinical investigators, would have placed them at increased risk of an adverse event or confused the result.

• Subjects with a personal or family history of seizures or frank psychiatric disorder.
• Females who had not ceased menstruation; a urine β-human chorionic gonadotrophin (β-HCG) test was to be performed at screening females who had ceased menstruation to exclude pregnancy as a cause.
• Females who were lactating.
• Subjects given antimalarial drugs for treatment within two weeks of study drug initiation.
• Subjects with clinically significant abnormalities (to include but not limited to abnormal hepatic or renal function) as determined by history, physical and routine blood chemistry and haematology values.
• Subjects with known hypersensitivity to any of the study drugs.
• Subjects unwilling to remain in the area, report for drug administration or blood drawing during the 3-4 month duration of the study.
• Subjects with G6PD deficiency (as determined by two separate qualitative tests per subject administered using distinct methods; methods used were visual dye and filter paper methods).
• Subjects with any of the following laboratory values: haemoglobin (Hb) <8g/dL, platelets <80,000/mm3, white blood cell count (WBC) <3000/mm3, creatinine >1.5mg/dL, alanine transaminase (ALT) >60IU or 1+ haematuria as detected by urine dipstick.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 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

Braden Hale, MD

Role: PRINCIPAL_INVESTIGATOR

US Naval Medical Research Unit

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-8340

Identifier Type: -

Identifier Source: org_study_id