None listed
Conditions
Interventions
FOR BOTH PARTS 1 AND 2, SUBJECTS WILL BE SCREENED TO CONFIRM ELIGIBILITY TO THE STUDY AND WILL BE TREATED WITH CQ ON DAYS 1 TO 3 (600 MG, 600 MG, 300 MG) TO TREAT THE BLOOD STAGE MALARIA INFECTION. IN
7500/µL AND >7S00/µL). FOLLOWING RANDOMISATION, THE STUDY WILL CONSIST OF A TREATMENT PERIOD OF 14 DAYS. SUBJECTS WILL STAY IN THE CLINIC AND RECEIVE DIRECTLY OBSERVED THERAPY FOR DAYS 1 TO 3, AND W
Sponsors
GlaxoSmithKline,
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. POSITIVE GIEMSA SMEAR FOR P. VIVAX 2. PARASITE DENSITY > 100 and 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
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 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).
Countries
Brazil, India, Peru, Thailand
Contacts
Public ContactSarita Mattos
GLAXOSMITHKLINE PERU S.A.
Outcome results
None listed