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 |
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| 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 |