SMART Study Design

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SMART Study Design
Participants with CD4 gt 350
n 3000
n 3000
Drug Conservation (DC) Strategy Stop or defer
ART until CD4 lt 250 then episodic ART based
on CD4 cell count to increase counts to gt 350
Virologic Suppression (VS) Strategy Use ART to
maintain viral load as low as possible throughout
follow-up
Follow-up for 6-9 years
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Total SMART Enrollment
(As of April 22, 2004)
Goal Enrolled Pct.

• Main SMART 6000 1834 31
• QOL and Healthcare 1200 917 76
  Utilization
• HIV Transmission Risk 600 569 95 Behavior
• Body Composition 300 171 57

Expanded new sample size
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Enrollment Breakdown

• Total 2004
  2004 Goal
• CPCRA Units 1422 214 25
• Associates 308 101 33
• Australia RCC 104 25 14

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The SMART 100

• HATG 160
• HART 155
• RAC 140
• NJCRI 113

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of Goal Jan-April 2004

• gt100 goal BARC NJCRI
• HART Denver
• HATG
• 80-99 goal ARAC Temple
• HFH WRAP
• REG
• lt80 goal CCSF RAC
• LaCARP SNJACT
• ProACT WSU

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SMARTBaseline Characteristics (N1834)
Age (mean, years) 47 Female 25 Race
African American or Black 41 Latino or
Hispanic 15White 41Other 3
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SMART Baseline

• ART- Naïve 4.9
• HIV-RNA lt 400 cp/mL 58.4
• Prior AIDS-related illnesses 24.8
• Hepatitis B 2.5
• Hepatitis C 20.2
• Likely mode of HIV infection
• Sexual contact, same sex 54
• Sexual contact, opposite 41
• Injection drug use 14
• Other / unknown 9

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Time on ARTPercent of Total Time
VS ideal No ART discontinuation gt 7 days DC
ideal Re-initiation for protocol-specified
reasons only, observed
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Completeness of Follow-up
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CPCRA RCC - US
CPCRA Units New Unit
Sub-sites SMART Associate Sites
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SMART Study - International
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SMART Study International
CPCRA RCC
Sydney RCC
London RCC
Copenhagen RCC
Brazil Canada Peru United States
Argentina Australia Japan New Zealand
Austria Belgium Denmark Finland Germany Norway Pol
and Portugal Spain
France Greece Ireland Italy Morocco Switzerland Un
ited Kingdom
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Cumulative Projected Enrollmentby Quarter and RCC
Patients
Jan 02 - Dec 03
Quarters
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New SMART Substudies

• Anal Dysplasia in start-up
• Neurology meeting with NIMH and NINDS on April
  14 funding likely
• Cardiovascular meeting with NHLBI on April 14
  funding possible.

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Continued Relevance of SMART

• Patients and providers seeking better strategies
  to optimize benefits and minimize risks of ART
• No other current study can answer this question
• Commitment and interest demonstrated by global
  partnership
• Results of SMART are relevant to the expansion of
  ART in resource limited countries