Table 2.
Summary of the clinical visits and laboratory testing for all 3 study groups
| Screening (≤14 days to Entry) |
Entry | Prior 2nd Dose |
Weeks 3 & 5 |
Week 7 (Monday/ Tuesday) PK visit |
Weeks 7 (Wednesday Thursday, Friday, Saturday, & Sunday) Washout |
Week 8 (Monday & Thursday) Washout |
Week 9 Washout |
Week 10 Start/End Washout |
|
|---|---|---|---|---|---|---|---|---|---|
| Informed Consent | x | ||||||||
| Physical Exam | x | x | x | ||||||
| Medical History | x | x | x | x | x | x | x | x | |
| Study Drug Dispensing | x | x | x | x | |||||
| Assess medication side effects | x | x | x | x | x | x | x | ||
| Adherence to Medication | x | x | x | ||||||
| HIV Serology (2 ml) | x | ||||||||
| Hematologya (2 mL) | x | ||||||||
| Chemistryb (2 mL) | x | x | x | xC | |||||
| Hepatitis B surface Ag (1 mL) | x | ||||||||
| DBS/Plasma PK Sample (3-5 mL) | x | x | x | x | x | x | x | ||
| Fingerstick (DBS) (0.1 mL) | x | x | x | x | x | x | x | ||
| Spot Urine Sample (5–10 mL) | x | x | x | x | x | x | x | ||
| Collection of 24-h Urine | x | x | |||||||
| Oral Fluid | x | x | x | xe | |||||
| PBMC (10 mL) | x | x | x | xd | x | x | |||
| Store plasma/EDTA Cell Pellet (3 mL) | X | ||||||||
| Total Blood Vol. (mL) | 10 mL | 0 mL | 15 mL | 17 mL | 39 mL | 25 mL | 20 mL | 15 mL | 32 mL |
aHematology: hemoglobin, hematocrit, RBC, MCV, WBC and differential, platelets
bChemistry: AST, ALT, total bilirubin, BUN, creatinine; electrolytes: sodium, potassium, chloride, bicarbonate, calcium, phosphate
cOnly at End of Week 10
dOnly On Monday of Week 8
eOnly on Wednesday, Thursday, Friday of Week 7