Time and Events Schedule for the Main SMART Study

Requirement	Screening visit (within 45 days before randomization)	Within 14 days before randomization	Follow-up visits Year 1 (Months)							Follow-up visits Years 2-8 (Every 4 months)
			1	2	4	6	8	10	12	4	8	12
Targeted health history, including HIV and supplemental diagnoses, clinical evaluation and concomitant treatments	X		X	X	X	X	X	X	X	X	X	X
AR treatment history	X	Advertisement
CD4 T cell count (determined locally)	X		X	X	X	X	X	X	X	X	X	X
Nadir CD4 T cell count available in the medical record	X
Plasma for HIV RNA level (determined locally)	X		X	X	X	X	X	X	X	X	X	X
Up to 3 most recent additional CD4 T cell counts and HIV RNA measurements available in the medical record	X
Documentation by laboratory report of hepatitis C antibody serostatus and hepatitis B serostatus	X
Blood sample (fasting or non-fasting) to determine: total cholesterol, LDL, HDL, VLDL cholesterol, triglycerides	X								X			X
Smoking status	X								X			X
Stored plasma sample for future HIV-related, CPCRA-approved research	X								X			X
Personal identifying information for ascertaining survival status (optional)	X
For women of childbearing potential, documented negative pregnancy test result on a specimen (serum or urine)		X
For women of child-bearing potential, self-reported pregnancy status				X	X	X	X	X	X	X	X	X
Current AR therapy and changes since last visit				X	X	X	X	X	X	X	X	X
Symptom severity	X				X		X		X	X	X	X
Changes in body appearance (patient self-report)	X								X			X
Plasma specimen for genotypic resistance testing	X
Stored plasma sample for future HIV drug resistance testing	X			X	X	X	X	X	X	X	X	X
Self-reported adherence to antiretroviral therapy (for patients who are currently prescribed AR therapy)	X				X		X		X	X	X	X
Demographic data	X

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