Evaluation of Weekly Tafenoquine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

249 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-05-31

Study Completion Date

1998-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Load only

Loading with tafenoquine 400 mg base for three days followed by placebo weekly.

Group Type EXPERIMENTAL

Tafenoquine

Intervention Type DRUG

Tafenoquine 200mg and 400 mg

Low weekly dose

Loading with tafenoquine 200 mg base for 3 days followed by tafenoquine 200 mg weekly.

Group Type EXPERIMENTAL

Tafenoquine

Intervention Type DRUG

Tafenoquine 200mg and 400 mg

High weekly dose

Loading with tafenoquine to 400 mg base for 3 days followed by tafenoquine 400 mg base weekly.

Group Type EXPERIMENTAL

Tafenoquine

Intervention Type DRUG

Tafenoquine 200mg and 400 mg

Placebo

Loading with placebo for 3 days followed by placebo once weekly.

Group Type EXPERIMENTAL

Placebo

Intervention Type OTHER

Placebo

Interventions

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Tafenoquine

Tafenoquine 200mg and 400 mg

Intervention Type DRUG

Placebo

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No