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

Katlama 2004.

Methods ANRS 097 trial 
 N=68 
 Randomized 
 Open 
 Fup: 56 weeks 
 w/o d/o: reported
Participants Eligibility :‐ 
 VL>75,000 
 CD4: na 
 ART: evidence of MDR virus; regimen >2PI + 2 NRTI +2NNRTI, duration: 6.2 years, 
 Age>15 years. 
 STI group: N=31, median age 41.3 years 97% males, 
 Control group: N=34 median age 38.6 years, 97% males,
Interventions 8 wks STI 
 Post STI ART: GIGHAART= 3‐4 NRTI + HU+ 1NNRTI + 3 PI;
Outcomes CD4 decline ‐10 cells/mm3(‐130‐15) in STI gp 
 CD4 cell count differences at week 24: 
 CD4 increase STI gp +51 
 CD4 increase control gp +7(p=0.047*) 
 CD4 cell count differences at week 48/52: 
 CD4 increase in STI gp +69 
 CD4 increase in control gp +7(*p=0.04)
VL rebound 
 VL rebound STI gp: +0.16 log copies(‐0.55 to 1.10)
VL differences between gps at week 12: 
 VL decline STI gp ‐1.91 (‐3.28 to +3.2) 
 VL decline Control gp ‐0.37 (‐3.47 to ‐.76) (p=0.008)
VL differences between gps at week 24: 
 VL decline STI gp ‐1.08(‐3.63‐0.33) 
 VL decline Control gp ‐0.29(‐3.6 to 0.45) (p =0.013)
Viral reversion: 
 STI gp 52% 
 Loss of mutations: 
 1 class 11% 
 2 classes 26% 
 3 classes 1%. 
 Adverse effects: 
 STI group 3/9 pts 
 Control gp 3/15 pts
Deaths: 2 pts in both STI and control gps
Notes 8 week STI followed by multidrug salvage regimen associated with better virological response.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Low risk A ‐ Adequate