Table 2 Summary of the clinical visits and laboratory testing for all 3 study groups

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

Hematology^a (2 mL)

x

Chemistry^b (2 mL)

x

x

x

x^C

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

x^e

PBMC (10 mL)

x

x

x

x^d

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