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 |
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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 |