Health Condition 1: null- Malaria with Plasmodium vivax
Conditions
Interventions
Intervention1: NA: NA
Intervention2: Tafenoquine(50 mg): Tafenoquine 50 mg will be dosed orally once on either Day 1 or Day 2 of the study as soon as
all screening test results are known and entry cri
Sponsors
GlaxoSmithKline Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the investigational product that may impact subject eligibility is provided in the IB/IB supplement(s), and locally approved prescribing information for CQ and PQ. Subjects eligible for enrolment in the study must meet all of the following criteria: Positive Giemsa smear for P. vivax Parasite density >100 and Age: >=16 years A female is eligible to enter and participate in this study if she is non-pregnant, non-lactating and if she is of: non-child bearing potential defined as: post-menopausal (12 months of spontaneous amenorrhea or 40 mIU/mL), pre-menopausal and has had a hysterectomy or a bilateral oophorectomy (removal of the ovaries) or a bilateral tubal ligation with medical report verification, negative pregnancy test or, child-bearing potential, has a negative pregnancy test at screening, and agrees to comply with one of the following during the treatment stage of the study and for a period of 90 days after stopping study drug: Use of oral contraceptive, either combined or progestogen alone used in conjunction with double barrier method as defined below Use of an intrauterine device with a documented failure rate of Double barrier method consisting of spermicide with either condom or diaphragm Male partner who is sterile prior to the female subjectâ??s entry into the study and is the sole sexual partner for that female. Complete abstinence from intercourse for 2 weeks prior to administration of study drug, throughout the study and for a period of 90 days after stopping study drug. A signed and dated informed consent is obtained from the subject or the subjectâ??s legal representative prior to screening. NB Assent is obtained from subjects The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions and is likely to complete the study as planned Willing to be hospitalized for 3 days and return to clinic for all follow-up visits including Day 180 QTc
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria must not be enrolled in the study: Mixed malaria infections (e.g. identified by Giemsa-stained smear or rapid diagnostic test) Severe vivax malaria as defined by WHO criteria. Severe vomiting (no food or inability to take food during previous 8 hours) Screening haemoglobin (Hb) concentration 7 g/dL. Glucose 6-phosphate dehydrogenase deficiency, assessed by a quantitative spectrophotometric phenotype assay: Males: Any subject with an enzyme level 70% of the site median value for G6PD normals will be excluded. Females: (i) Those females with a screening Hb >= 10 g/dL will only be excluded if their enzyme level is 70% of the site median value for G6PD normals. Those females with Hb >=7 but 10 g/dL will be excluded if an enzyme level is not 90% of the site median value for G6PD normals. Liver function test ALT 2 x ULN. Any clinically significant concurrent illness (e.g. pneumonia, septicaemia), pre-existing conditions (e.g. renal disease, malignancy), conditions that may affect absorption of study medication (e.g. vomiting or severe diarrhoea) or clinical signs and symptoms of severe cardiovascular disease (e.g. uncontrolled congestive heart failure or severe coronary artery disease). These abnormalities may be identified on the screening history and physical or laboratory examination Subject has taken antimalarials (e.g. ACT, mefloquine, primaquine, chloroquine) or drugs with anti-malarial activity within the past 30 days by history. History of allergy to chloroquine, mefloquine, tafenoquine, primaquine or to any other 4- or 8-aminoquinolines. Any contraindications to chloroquine or primaquine administration including a history of porphyria, psoriasis or epilepsy (please refer to chloroquine and primaquine locally approved prescribing information). Subject who has previously received study medication for this protocol (all parts) or has received treatment with any other investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication. History of illicit drug abuse or heavy alcohol intake within 6 months of the study. Subjects who have taken or will likely require the use of medications from the prohibited medication list (see Appendix 5) which include the following classes: Histamine-2 blockers and antacids. Drugs with haemolytic potential. Drugs known to prolong the QTc interval.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse efficacyTimepoint: Relapse efficacy six months post-dosing | — |
Secondary
| Measure | Time frame |
|---|---|
| Fever Clearance TimeTimepoint: Time from first dose of treatment to the time when body temperature falls to normal and remains normal for at least 48 hours.;Parasite Clearance TimeTimepoint: Time needed to clear asexual parasite from the blood defined as parasite numbers falling below the limit of detection in the thick blood smear and remaining undetectable 6-12 hours later.;Relapse efficacyTimepoint: Relapse efficacy four months post-dosing;Time to relapseTimepoint: Six months post- dosing | — |
Countries
Bangladesh, Brazil, India, Peru, Thailand
Contacts
Public ContactDr Jeroze Dalal
GlaxoSmithKline Pharmaceuticals Ltd
Outcome results
None listed