NCT02488980

An Evaluation of Weekly Tafenoquine

A Randomized, Double Blind, Placebo Controlled Evaluation of Weekly Tafenoquine (WR 238605/SB252263) Compared to Mefloquine for Chemosuppression of Plasmodium Falciparum in Western Kenya

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 306 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Tafenoquine	Tafenoquine 200 mg for three days followed by Tafenoquine 200 mg 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.
DRUG	Placebo	Placebo for three days followed by placebo once a week for 24 weeks

Timeline

• Start date: 2000-05-01
• Primary completion: 2000-10-01
• Completion: 2003-03-01
• First posted: 2015-07-02
• Last updated: 2017-05-30
• Results posted: 2017-02-24