Evaluation of Weekly Tafenoquine

United States Army Medical Research and Development Command (USAMRDC)

Status and phase: Completed; Phase 2

Conditions: Malaria

Treatments: Drug: Tafenoquine; Other: Placebo

Study type: Interventional

Funder types: Other U.S. Federal agency; Industry

Identifiers

NCT02491606

A-7540

Details and patient eligibility

About

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.

Enrollment: 249 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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249 participants in 4 patient groups

Load only

Experimental group

Description:

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

Treatment:

Drug: Tafenoquine

Low weekly dose

Experimental group

Description:

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

Treatment:

Drug: Tafenoquine

High weekly dose

Experimental group

Description:

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

Treatment:

Drug: Tafenoquine

Placebo

Experimental group

Description:

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

Treatment:

Other: Placebo