Table 2.

Schedule of Procedures/Evaluations

Visit Window		Up to 7 days after screen	+/− three (3) days						+/− seven (7) days					Treatment Response	Post Early Termination Visitg
Visit	Screen	Baseline	WK 2	WK 4	WK 8	WK 12	WK 17	WK 22	WK 26	MO 9	MO 12	MO 15	MO 18
Informed Consent	X
Inclusion/Exclusion	X	X
Demographics, medical history	X
Contact information	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X
Symptoms		X	X	X	X	X	X	X	X	X	X	X	X	X	X
Concomitant medications		X	X	X	X	X	X	X	X	X	X	X	X	X	X
Adverse events			X	X	X	X	X	X	X						X
Interval medical history										X	X	X	X	X
Height	X
Weight	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X
Chest radiograph	X						Xf		Xf					X
Visual tests		X		X
HIV test	X
CD4, HIV viral load (if HIV-pos)	Xa
Pregnancy testing	X
Randomization		X
Sputum for smear and cultureb	X	X	X	X	X	X	XX	XX	XX	XX	XXc	XX	XXc	XXX
Sputum for rapid molecular test, if available at site	X
Storage of Mtb bacterial isolate	X	X					X	X	X	X	X	X	X	X
Diabetes screend	X
ALT, bilirubin, creatinine, hemoglobin, WBC with differential, platelets	X		X	X	X	X	X	X							X
Serum albumin, potassium	X
PK sampling for TB drugs			within this interval
Blood sample for pharmacogenomics		Obtain anytime after enrollment
EFV1: Plasma for EFV PK	At screening or baseline			X	X		X
EFV1: HIV viral load	At screening or baseline				X		X
EFV2: Plasma for EFV PK				Obtain at about 4 weeks after starting EFV AND at about 8 weeks after starting EFV				X
EFV2: HIV viral load	Required per eligibility criteria			Obtain once at about 8 weeks after starting EFV				X
Sputum, blood, urine for research		X	X	X	X		Xe		Xe					X
Contact central study clinician														X

NOTES

^aUnless results of a test performed at or within 30 days prior to screening are available.

^bAll sputa should be sent to the designated study laboratory with the exception of the screening specimen, which may be evaluated at any locally acceptable laboratory. If a screening specimen has been found to be smear or culture positive at a non-study laboratory, then either store the isolate if culture positive from the non-study laboratory or get an additional specimen for culture and storage of isolate. Two specimens (i.e. one at screening and one at baseline) are required prior to initiation of study treatment. At least two (2) sputa should be obtained at each of weeks 17, 22, 26 and at each of months 9, 12, 15, and 18.

^cIf both of the month 12 sputa or both of the month 18 sputa are contaminated, then the participant should be asked to provide at least two (2) additional sputa as soon as possible after contamination is recognized.

^dHemoglobin A1C is the preferred test. If such testing is not available, then fasting or random blood glucose can be measured.

^eTo be obtained at the end-of-study treatment visit (i.e. either week 17 or week 26).

^gThis visit occurs approximately 14 days after stopping study drugs.