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. 2006 Jul 19;2006(3):CD006148. doi: 10.1002/14651858.CD006148

Youle 2000.

Methods N=35 
 Non randomized 
 W/o: unclear 
 Follow up: unclear
Participants Eligibility:‐ 
 VL>50,000 RNA cop/ml, 
 ART: on PI based 4 drug regimen for 6 months, 
 Pre STI ART duration: >4.4 years 
 Baseline CD4 125 (36‐254) 
 Baseline VL 540,000 (72,000‐750,000)
Interventions TI 1‐2 months 
 Washout period present
Outcomes CD4 differences b/w control and STI gps: 
 0‐4 months:85 cells/mm3 ( p<0.001) 
 5‐8 months: 47 cells/mm3 (p<0.001) 
 9‐20 months: 31 cells/mm3 (p<0.11) 
 Control group mean CD4 counts higher by 85 cells p<0.001
VL differences b/w STI and Control gps: 
 0‐4 months: +1.2 log cop/ml higher in STI gp (p<0.001), 
 4‐20 months: 0.8 log cop/ml suppressed both gps
Viral reversion: 64% pts 
 A/E: no difference between gps 
 Death: 8 pts both gps (HR=2.57(1.2‐5.5) (p=0.01) 
 Disease events: 
 17 pts STI gp 
 5 pts control gp 
 HR=6.04(1.8‐20.8) 
 Quality of life at 2 months: 
 STI gp: SF12 score +1.7 
 Control gp: SF12 score ‐0.4
Notes 1.Greater loss of CD4 soon after interruption (p=0.03). 
 2. Faster decline in CD4 within the first three weeks.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk D ‐ Not used