Evaluation of Weekly Tafenoquine

Evaluation of Weekly Tafenoquine (SB 252263 / WR 238605) Compared to Placebo for Chemosuppression of Plasmodium Falciparum in Western Kenya

This study is a phase 2b, placebo controlled, randomized, blinded study of the efficacy of WR 238605, a new primaquine analog, compared to placebo as chemosuppression of P. falciparum malaria in Nyanza Province, western Kenya.

Study Overview

• Status: Completed
• Conditions: Malaria
• Intervention / Treatment: Other: Placebo; Drug: Tafenoquine

• Study Type: Interventional
• Enrollment (Actual): 249
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy subjects (male or female)
2. Age of 18-55 years
3. Residing in one of the study villages of the Nyanza Province for the entire study

Exclusion Criteria:

1. Any cardiovascular, liver, neurologic, or renal functional abnormality which in the opinion of the clinical investigators would place the subject at increased risk of an adverse event or confuse the result.
2. Female subjects who were pregnant (Positive serum / plasma -HCG as tested within 48 hours of first drug administration).
3. Use of antimalarial drugs not prescribed by study physicians within 2 weeks of study drug initiation.
4. Clinically significant abnormalities (including but not limited to abnormal hepatic or renal function) as determined by history, physical and routine blood chemistries and complete blood count.
5. Known hypersensitivity to any study drug.
6. Unwilling to remain in area and report for drug administration and blood drawing during the duration of the study.
7. Glucose 6 Phosphate Dehydrogenase (G6PD) deficiency.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Load only; Loading with tafenoquine 400 mg base for three days followed by placebo weekly.	Drug: Tafenoquine; Tafenoquine 200mg and 400 mg
Experimental: Low weekly dose; Loading with tafenoquine 200 mg base for 3 days followed by tafenoquine 200 mg weekly.	Drug: Tafenoquine; Tafenoquine 200mg and 400 mg
Experimental: High weekly dose; Loading with tafenoquine to 400 mg base for 3 days followed by tafenoquine 400 mg base weekly.	Drug: Tafenoquine; Tafenoquine 200mg and 400 mg
Experimental: Placebo; Loading with placebo for 3 days followed by placebo once weekly.	Other: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prophylactic outcome.	Thick blood films were stained with Giemsa stain and malaria parasite counts determined by counting the number of asexual parasites per 200 white blood cells. A blood slide was not considered negative until an examination of 200 oil immersion fields showed no parasites.	13 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prophylactic outcome after 7 weeks	Thick blood films were stained with Giemsa stain and malaria parasite counts determined by counting the number of asexual parasites per 200 white blood cells. A blood slide was not considered negative until an examination of 200 oil immersion fields showed no parasites.	7 Weeks
Prophylactic outcome after 10 weeks	Thick blood films were stained with Giemsa stain and malaria parasite counts determined by counting the number of asexual parasites per 200 white blood cells. A blood slide was not considered negative until an examination of 200 oil immersion fields showed no parasites.	10 Weeks

Collaborators and Investigators

• Sponsor: U.S. Army Medical Research and Development Command
• Collaborators: SmithKline Beecham
• Investigators: Principal Investigator: A.J Oloo, Kenya Medical Research Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 1997
• Primary Completion (Actual): September 1, 1997
• Study Completion (Actual): September 1, 1998

Study Registration Dates

• First Submitted: June 30, 2015
• First Submitted That Met QC Criteria: July 2, 2015
• First Posted (Estimate): July 8, 2015

Study Record Updates

• Last Update Posted (Actual): September 13, 2018
• Last Update Submitted That Met QC Criteria: September 12, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Malaria; Anti-Infective Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Tafenoquine
• Other Study ID Numbers: A-7540