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 |
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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 |