From: Methodological standards in non-inferiority AIDS trials: moving from adherence to compliance
 | Δ Maximum difference % (hypothesis) | δ (%)* | UBCI§ of δ (%) | Non-inferiority D-value (type of analysis) | Superiority P-value (ITT) | Abstract authors' conclusion as compared with active-control for primary endpoint |
---|---|---|---|---|---|---|
CNAAB3005 | 12 (E) | 7.3 | 14.3 | 0.17 (OT) | 0.90 | Was equivalent to |
NEFA | 13.5 (NI) | Â | Â | Â | Â | Â |
(a) | Â | 3.9 | 9.8 | < 0.001 (ITT) | 0.20 | No conclusion |
(b) | Â | 8.5 | 15.8 | 0.14 (OT) | 0.035 | A trend toward higher rate of [failure] |
BEST | 15 (NI) | 15.7 (ITT) | 25.9 (ITT) | 1.0 (ITT) | 0.003 | Superiority of control in ITT |
 |  | 0.7 (OT) | 7.2 (OT) | < 0.001 (OT) | 1.0 (OT) | Non-inferiority in OT |
2NN | 10 (E) | Â | Â | Â | Â | Â |
(a) | Â | 5.9 | 14.0 | 0.36 (ITT) | 0.15 | Showed similar efficacy |
(b) | Â | 7.7 | 14.6 | 0.56 (OT) | 0.091** | Showed similar efficacy |
(c) | Â | 15.4 | 23.6 | 0.24 (ITT) | 0.0003 | Did not show efficacy |
903 | 10 (NI) | 4.1 | 10.3 | 0.07 (ITT) | 0.19 | Highly effective and comparable*** |
SOLO | 12 (NI) | -1.0 | 6.1 | < 0.001 (ITT) | 0.78 | Provided durable [efficacy] |
FTC-303 | 15 (NI) | 5.0 | 12.9 | < 0.01 (ITT) | 0.234 | Was equivalent to |
EPV20001 | 12 (E) | -0.1 | 3.6 | < 0.001 (OT) | 0.81 | Regimens were equivalent |
ALIZE | 15 (NI*) | -2.9 | 3.6 | < 0.001 (ITT) | 0.39 | Associated with sustained [efficacy] |
CNA30024 | 12 (NI) | -0.8 | -6.3 | < 0.001 (ITT) | 0.82 | Not inferior to |
BMS-2004 | 10 (NI) | 3.9 | 9.7 | 0.043 (OT) | 0.16 | As efficacious as |
ESS40013 | 12 (NI) | 6.1 | 13.5 | 0.09 (OT) | 0.77 | Maintained [efficacy] |
SEAL | 12 (NI*) | -1.5 | 4.3 | < 0.001 (ITT) | 0.61 | Not inferior to |
BMS-045 | NA (NI) | Â | Â | Â | Â | Â |
(a) | Â | 8.0*** | 20.4*** | NA (ITT) | 0.21 | As effective as |
(b) | Â | 19.5*** | 32.2*** | NA (ITT) | 0.003 | Efficacy was lower than |
CNA30021 | 12 (NI) | 2.2 | 6.6 | < 0.001 (OT) | 0.61 | Not inferior to |
CONTEXT | NA (NI) | Â | Â | Â | Â | Â |
(a) | Â | 14.0*** | 28.0*** | NA (OT) | 0.07 | Not shown to be as effective as |
(b) | Â | 10.0*** | 23.0*** | NA (ITT) | 0.30 | Not shown to be as effective as |
SHAART | 15 (NI) | 2.1 | 17.4 | 0.13 (ITT) | 0.784 | Not inferior to |
934 | 13 (NI) | -3.5 | 0.5 | < 0.001 (OT) | < 0.005 | Fulfilled criteria for non-inferiority and proved superior |