A MULTI-CENTRE, DOUBLE-BLIND, RANDOMISED, PARALLEL-GROUP, ACTIVE CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF TAFENOQUINE (SB-252263, WR238605) IN SUBJECTS WITH PLASMODIUM VIVAX MALARIA.

Not Applicable

• Registration Number: PER-031-11
• Lead Sponsor: GlaxoSmithKline,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-25
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 155

Inclusion Criteria

1. POSITIVE GIEMSA SMEAR FOR P. VIVAX
2. PARASITE DENSITY > 100 and < 200,000/µL
3. AGE: ≥ 16 YEARS
4. A FEMALE IS ELIGIBLE TO ENTER AND PARTICIPATE IN THIS STUDY IF SHE IS NON-PREGNANT, NON-LACTTATING AND IF SHE IS OF:
A. NON-CHILD BEARING POTENTIAL DEFINED AS: POST-MENOPAUSAL (12 MONTHS OF SPONTANEOUS AMENORRHEA OR 6 MONTHS OF SPONTANEOUS AMENORRHEA WITH SERUM FSH> 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 OR,
B. CHILD-BEARING POTENTIAL, HAS A NEGATIVE SERUM 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 OF PROGESTOGEN ALONE USED IN CONJUNCTION WITH DOUBLE BARRIER METHOD AS DEFINED BELOW
. USE OF AN INTRAUTERINE DEVICE WITH A DOCUMENTED FAILURE RATE OF <1% PER YEAR
. DOUBLE BARRIER METHOD CONSISTING OF SPERMICIDE WITH EITHER CONDOM OR DIAPHRAGM
. MALE PARTNER WHO IS STERILE PRIOR TO THE FEMALE SUBJECT´S ENTRY INTO THE STUDY AND IS THE SOLE SEXUAL PARTNER FOR THAT FEMALE

Exclusion Criteria

1. MIXED MALARIA INFECTIONS (e.g. IDENTIFIED BY GIEMSA-STAINED SMEAR OR RAPID DIAGNOSTIC TEST)
2. SEVERE VIVAX MALARIA AS DEFINED BY WHO CRITERIA (SEE APPENDIX 4).
3. SEVERE VOMITING (NO FOOD OR INABILITY TO TAKE FOOD DURING PREVIOUS 8 HOURS)
4. SCREENING HAEMOGLOBIN (Hb) CONCENTRATION <7 g/dL
5. 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.
WOMEN:
(I) THOSE WOMEN 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.
(II) THOSE FENMALES 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.
6. LIVER FUNCTION TESTS ALT > 2 x ULN.
7. 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 DIARRHEA) OR CLINICAL SIGNS AND SYMPTOMS OF SEVERE CARDIOVASCULAR DISEASE (e.g. UNCONTROLLED CONGESTIVE HEART FAILURE OR SEVERE CORONARY ARTERY DISEASE).

Study & Design

• Study Type: Interventional
• Study Design: Not specified