Table 1.

Schedule of events.

Study visit	Screening	Enrollment	Wk 0	Wk 1	Wk 2	Wk 4	Wk 8	Wk 12	Unscheduled visit
ARTa day	Not specified	Aim for −7 to 0	0	7±4	14±4	28±4	56±4	84±7	Not specified
Document HIV status	x
Screening ICFb	x
Enrollment ICF		x
Study drug dispensed			x		x
Symptomsc	x	x	x	x	x	x	x	x	x
Karnofsky score	x		x	x	x	x	x	x	x
Pill countd				x	x	x	x	x	x
HR-QOLe assessments			x			x		x
Examination	x	If	x	x	x	x	x	x	x
Laboratory investigationsg	x	I	x		x	x		x	I
CD4 count, HIV viral load	x							x
Serum HBsAgh	x
Serum CrAgi	x
Urinary pregnancy test	x	I	I	I	I	I	I	I	I
Storage bloods and immunology assays			x		x	x		x	If IRIS suspected
Storage urine			x					x	If IRIS suspected
Chest radiograph	I		x						If IRIS suspected
Sputum Xpert MTB/RIFj, TB culture, and DSTk	x					x		x
Initiate ART			x

^aART: antiretroviral therapy.

^bICF: informed consent form.

^cSymptoms and specific screening for adverse events and TB-IRIS.

^dPill count: ART and study drug week 1-4.

^eHR-QOL: health-related quality of life.

^fI: if clinically indicated.

^gLaboratory investigations: full blood count with leucocyte differentiation, sodium, potassium, creatinine, glucose, bilirubin, alanine aminotransferase, alkaline phosphatase, C-reactive protein.

^hHBsAg: hepatitis B surface antigen.

ⁱCrAg: cryptococcal antigen.

^jMTB/RIF: Mycobacterium tuberculosis, resistance to rifampicin.

^kDST: drug sensitivity testing.