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Table 1 Characteristics of the 18 non-inferiority studies

From: Methodological standards in non-inferiority AIDS trials: moving from adherence to compliance

  Power (%) Double blind Experimental arm(s) (ITT sample size) Control arm (ITT sample size)
CNAAB3005 [10] NA Yes ABA (262) PI-based regimen (265)
NEFA [11] 90 No (a) NVP BID (155) EFV QD (156)
    (b) ABA BID (149)  
BEST [12] 90 No IDV/RITO BID (162) IDV TID (161)
2NN [13] 80 No (a) NVP QD (220) EFV (400)
    (b) NVP BID (387)  
    (c) NVP+EFV (209)  
903 [14] 80 Yes TNF (299) Stavudine (301)
SOLO [15] 85 No FPV/RITO QD (322) Nelfinavir BID (327)
FTC-303 [16] 85 No FTC QD (294) 3TC BID (146)
EPV20001 [17] 80 Yes 3TC QD (278) 3TC BID (276)
ALIZE [18] 80 No FTC-ddI-EFV QD (178) PI-based regimen BID/TID (177)
CNA30024 [19] 85 Yes ABA BID (324) AZT BID(325)
BMS-2004 [20] 90 Yes Atazanavir (405) EFV (405)
ESS40013 [21] 80 No Stop EFV (141) Continue EFV (141)
SEAL [22] 80 No 3TC+ABA QD (130) 3TC+ABA BID (130)
BMS-045 [23] NA No (a) ATA/RITO QD (120) LOPI/RITO BID (123)
    (b) ATA/SAQUI (115)  
CNA30021 [24] 90 Yes ABA QD (384) ABA BID (386)
CONTEXT [25] NA No (a) FPV/RITO QD (105) LOPI/RITO BID (103)
    (b) FPV/RITO BID (107)  
SHAART [26] 80 No ABA BID (68) NVP BID (66)
934 [27] 85 No TNF+FTC QD (255) AZT+3TC BID (259)
  1. *one-sided 5% type I error
  2. ** one-sided 1.25% type I error
  3. Abbreviations : NA: not available; E: equivalence; NI: non-inferiority; ABA: abacavir PI: protease inhibitor ; NVP: nevirapine ; EFV: efavirenz ; IDV: indinavir ; RITO: ritonavir ; TNF : tenofovir ; FPV: fosamprenavir; FTC : emtricitabine; 3TC: lamivudine ; ddI: didanosine ; AZT : zidovudine ; QD: once-a-day ; BID: twice-a-day ; TID three times-a-day