Evaluation of Weekly Tafenoquine

Phase 2

Completed

• Conditions: Malaria
• Interventions: Other: Placebo; Drug: Tafenoquine

• Registration Number: NCT02491606
• Lead Sponsor: U.S. Army Medical Research and Development Command

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1997-05
• Primary Completion: 1997-09
• Study Completion: 1998-09
• Study First Submitted: 2015-06-30
• Study First Submitted QC: 2015-07-02
• Study First Posted: 2015-07-08
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-12
• Last Update Posted: 2018-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 249

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Loading with placebo for 3 days followed by placebo once weekly.
Load only	Tafenoquine	Loading with tafenoquine 400 mg base for three days followed by placebo weekly.
Low weekly dose	Tafenoquine	Loading with tafenoquine 200 mg base for 3 days followed by tafenoquine 200 mg weekly.
High weekly dose	Tafenoquine	Loading with tafenoquine to 400 mg base for 3 days followed by tafenoquine 400 mg base weekly.

Primary Outcome Measures

Name	Time	Method
Prophylactic outcome.	13 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.

Secondary Outcome Measures

Name	Time	Method
Prophylactic outcome after 7 weeks	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.
Prophylactic outcome after 10 weeks	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.