Evaluation of Weekly Tafenoquine

NCT02491606 | Completed Phase 2

• 1 other identifier: A-7540
• Study Type: interventional
• Target: 249
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Malaria

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Prophylactic outcome after 7 weeks

  7 Weeks

• Prophylactic outcome after 10 weeks

  10 Weeks

Study Arms (4)

Load only

EXPERIMENTAL

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

Drug: Tafenoquine

Low weekly dose

EXPERIMENTAL

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

Drug: Tafenoquine

High weekly dose

EXPERIMENTAL

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

Drug: Tafenoquine

Placebo

EXPERIMENTAL

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

Other: Placebo

Interventions

Tafenoquine DRUG

Tafenoquine 200mg and 400 mg

High weekly dose; Load only; Low weekly dose

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.
• Female subjects who were pregnant (Positive serum / plasma -HCG as tested within 48 hours of first drug administration).
• Use of antimalarial drugs not prescribed by study physicians within 2 weeks of study drug initiation.
• 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.
• Known hypersensitivity to any study drug.
• Unwilling to remain in area and report for drug administration and blood drawing during the duration of the study.
• Glucose 6 Phosphate Dehydrogenase (G6PD) deficiency.

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command: lead
• SmithKline Beecham: collaborator

Related Publications (1)

• 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.

  PMID: 28495354 DERIVED

MeSH Terms

Conditions

Malaria

Interventions

tafenoquine

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• A.J Oloo

  Kenya Medical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2015
• First Posted: July 8, 2015
• Study Start: May 1, 1997
• Primary Completion: September 1, 1997
• Study Completion: September 1, 1998
• Last Updated: September 13, 2018

Record last verified: 2018-09