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

Lawrence 2003.

Methods CPCRA 064 trial 
 N=270 
 Randomized 
 Open 
 Fup= 11.6 months 
 prematurely terminated 
 w/o d/o reported
Participants Eligibility:‐ 
 HIV infection >13 yrs,HIV RNA >5,000 copies/ml, MDR virus, stable ART regime, STI N= 138 
 STI median age 45 years 8.7%, Females, 132 control group, 43.9 years mean age, 9.8% 
 Baseline CD4 153 cells/mm3 
 Baseline VL 5.0 copies/ml 
 ART: 2.2 NNRTI +2.5PI+1.0NNRTI 
 Mut: 10.8
Interventions 4 month STI
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: 
 STI gp 17 pts 
 Control gp 5 pts 
 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 Continue with an optimized ARV regimens and avoid the use of STI
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Low risk A ‐ Adequate